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Positron emission tomography A strategy for provision in the UK A report of the Intercollegiate Standing Committee on Nuclear Medicine Representing the Royal College of Physicians of London, the Royal College of Physicians and Surgeons of Glasgow, the Royal College of Physicians of Edinburgh, the Royal College of Pathologists, the Royal College of Radiologists and the British Nuclear Medicine Society January 2003

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Page 1: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

Positron emissiontomography

A strategy for provision in the UK

A report of the

Intercollegiate Standing Committee on Nuclear Medicine

Representing the Royal College of Physicians of London, the Royal

College of Physicians and Surgeons of Glasgow, the Royal College of

Physicians of Edinburgh, the Royal College of Pathologists, the Royal

College of Radiologists and the British Nuclear Medicine Society

January 2003

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ii

ROYAL COLLEGE OF PHYSICIANS OF LONDON11 St Andrews Place, London NW1 4LE

Registered Charity No 210508

ROYAL COLLEGE OF RADIOLOGISTS38 Portland Place, London W1N 4JQ

Copyright © 2003 Royal College of Physicians of London

ISBN 1 86016 170 7

Cover design by Merriton Sharp

Typeset by Dan-Set Graphics, Telford, Shropshire

Printed in Great Britain by Sarum ColourView Group, Salisbury, Wiltshire

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Contents

Foreword v

Executive summary and recommendations vii

PART 1: A STRATEGY FOR THE PROVISION OF POSITRON EMISSION

TOMOGRAPHY IN THE UK

1 Introduction 3

Background 3

2 Clinical PET: areas of use 5

The role of PET in oncology 5

The role of PET in cardiology and cardiac surgery 7

The role of PET in neurology and neuropsychiatry 7

Cost effectiveness 7

3 The requirements of a national PET service 9

Equipment and personnel 10

4 Current problems and their solutions 11

Problems with service provision 11

Problems with establishing PET in the UK 12

5 Suggested strategy for the provision of a PET service 13

6 Conclusion 16

PART 2: CLINICAL INDICATIONS FOR POSITRON EMISSION TOMOGRAPHY

IMAGING: CURRENT ICSCNM SUGGESTIONS

Introduction 19Radiation hazards 19Breast feeding 20Pregnancy and protection of the foetus 20The clinical indications table 20

Clinical indications for positron emission tomography 21

iii

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APPENDICES

1: Imaging with a distant supply of tracer: the minimum establishment 292: Imaging with full production of tracer: the minimum establishment 323: Training issues 38

References 39

Bibliography 41

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Foreword

The Intercollegiate Standing Committee on Nuclear Medicine (ICSCNM) is committed to the

maintenance of standards in, and the development of, nuclear medicine and radionuclide

radiology in a way which contributes to the care of patients.

Nuclear medicine technologies are developing at a great pace and, in keeping with the molecular

developments in medicine, positron emission tomography (PET) is now capable of providing

molecular imaging. Clinical PET’s contribution to the management of patients with cancer is

growing in terms of diagnosis, staging, restaging and the monitoring of response to therapy. The

new combination technology of PET-CT scanners will impact on radiotherapy planning as well

as on assessing gene therapy and early tumour response. Although oncology is the major area

of PET usage, applications in neurology and cardiology are apparent and will develop in the

future.

As with all new technologies, setting up a service can be difficult both in terms of capital cost

and staff training. Currently the access to PET services for UK patients is extremely limited and

inequitable in geographical location. For PET to be developed and used appropriately and to a

high standard, the constituent bodies of the ICSCNM felt that a strategic view should be available

to allow decisions to be made for a rational implementation of a service.

This document is therefore intended to provide a clear indication of the potential value and

practical implications of the development of a PET service. It should also act as a stimulus to

those in relevant patient care to press for the provision of such a service.

A working party of the ICSCNM (consisting of Dr MJ O’Doherty (Chairman), Prof I McCall

and Dr TO Nunan) produced this document, which has since been reviewed and modified by

all members of the committee. It has therefore been endorsed by the Royal College of Physicians

of London, the Royal College of Physicians and Surgeons of Glasgow, the Royal College of

Physicians of Edinburgh, the Royal College of Pathologists, the Royal College of Radiologists

and the British Nuclear Medicine Society. The document will be available on the websites of the

Royal College of Physicians, the Royal College of Radiologists and the British Nuclear Medicine

Society.

Special thanks are extended to Ms M Dakin (of Guy’s and St Thomas’ Clinical PET Centre) for

the financial information.

January 2003 PROFESSOR IAIN MCCALL

Chairman, ICSCNM

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Executive summary and recommendations

SUMMARY

Positron emission tomography (PET) has been in use for over 20 years as a research tool, and

over the last decade in a clinical role. The major clinical applications of PET are in the areas of

oncology, cardiology and neurology, with over 85–90% of the workload in oncology. There have

been around 15,000 publications related to PET, and although the majority of these have been

small retrospective studies, all major studies have had similar findings. The literature lacks

randomised controlled trials (with the exception of lung cancer1) and large prospective series

or cost-effectiveness analyses (other than modelling studies). Despite this, PET scanning has

been adopted throughout the USA and Europe, gaining Centers for Medicare and Medicaid

Services (CMS, previously known as the Health Care Financing Administration or HCFA)

approval for reimbursement in patients with certain cancers and cardiac conditions in the US.

There are over 160 sites in the USA and over 120 sites in Europe (80 of these are in Germany).

PET is a technology that uses short-lived radionuclides (with half-lives currently ranging from

2 to 110 minutes) attached to tracers to examine metabolic processes associated with health and

disease. These functions are often altered by disease and precede changes that can be visualised

by cross-sectional imaging (eg computed tomography (CT) or magnetic resonance imaging

(MRI)). PET radionuclides are produced in cyclotrons which are available in a variety of sizes

and energies. The most commonly produced radionuclide is fluorine-18 (F-18), but others

include nitrogen-13 (N-13), carbon-11 (C-11) and oxygen-15 (O-15). F-18 has the advantage

of having a longer half-life (110 minutes) and can be attached to a molecule that mimics glucose

metabolism, fluorodeoxyglucose, to produce 18F-FDG. Cancer cells have altered glucose

metabolism and therefore FDG is a major tracer used in the assessment of cancer.

Evidence of the diagnostic accuracy of PET scanning is based on traditional full-ring dedicated

PET, with very few publications using gamma camera coincidence imaging (GCI). The technology

for GCI is currently inferior to dedicated PET scanners and is unlikely to have the same versatility.

Health technology assessment is notoriously difficult to undertake since the technology is

advancing so rapidly. The studies that have been performed demonstrate that PET is more

accurate in detecting malignant disease than conventional imaging, but is often best used in

combination with conventional cross-sectional imaging in the assessment of cancer patients.

Modelling studies in pulmonary nodules and lung cancer have been carried out using published

sensitivities and specificities. The points of interest are that the predications of these studies

appear to support the findings from recent prospective research and a recent randomised

controlled trial of lung cancer and PET. There are a number of studies in different cancer groups

demonstrating change in management as a result of PET scanning. In one study, 62 out of 102

patients with lung cancer being assessed for surgery had their management changed, having

been staged by conventional means.2

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PET in the UK has been severely restricted by the lack of availability of scanners and cyclotrons.

Clinical PET was introduced into the UK at Guy’s and St Thomas’ Hospitals in 1992; the unit

now has two scanners and has rapidly become inundated with work, such that 2,000 patient

studies are being performed per annum on patients travelling from Scotland, Wales and all corners

of England. Since 1992 only three other dedicated clinical PET facilities have developed, all of

which are in London. Research scanners have been established in London, Manchester, Cambridge

and Aberdeen. All of these have access to a cyclotron and radiotracer production facilities.

PET scanning has been limited by the lack of positron-emitting tracers caused by the small

number of cyclotrons. The present cyclotrons can supply 18F-FDG to hospitals within an

approximate two-hour travel-time radius. However, radionuclides currently used for vascular

flow measurements all have a very short half-life and can only be used in scanners immediately

adjacent to the cyclotron. The key to delivering a service lies in deciding how many centres and

which studies are required.

PET should be available to all cancer centres for early diagnosis, staging and the identification of

tumour recurrences. These tasks will constitute approximately 85–90% of a PET centre’s work. It

should also be available to tertiary referral centres where there is substantial work being undertaken

on neuropsychiatric conditions (eg epilepsy), and possibly dementing illnesses (eg Alzheimer’s

disease) and also the evaluation of cardiac muscle viability prior to coronary artery surgery (see

Part 2). These latter uses will only make up the remaining 10–15% of the workload.

A dedicated PET camera could perform between 1,000 and 1,600 patient studies per year,

depending on the complexity and type of study. With new technologies, such as PET-CT cameras,

their number may increase. Therefore a knowledge of the population base which is likely to

provide at least that number is required. It is estimated that a population of approximately

1–1.5 million people would have 700–750 patients per annum falling in to the cancer types which

from the body of evidence available would benefit from PET scanning, ie lung cancer, metastatic

or recurrent colorectal cancer and lymphoma. In addition to these groups the evidence for the

role of PET in a larger range of cancers is becoming established (see Part 2). Most cancer centres

in the UK subserve this population of patients. The establishment of a PET centre in each cancer

network would be a useful start to the process.

PET centre optionsThere would need to be two types of PET centre developed in the UK: dedicated full-ring PET

scanners in conjunction with a cyclotron and radiochemistry production facility, and stand-

alone PET scanners. The staffing of these centres is outlined in Part 1 of this document and in

the appendix. The delivery of a PET service is expensive; however, the calculated incremental

cost-effectiveness ratios (ICERs) are low. The location of each type of centre would need to be

carefully considered to give optimum access for the patient population. The likely capital cost

of a PET scanner facility is £1,285,050 and the cyclotron/radiochemistry facility is an additional

£1,469,700. Revenue consequences will vary depending on the service offered, but for the scanner

alone the estimate based on 1,000 patients is £585,900 (see the appendices for a more detailed

analysis of costs).

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Staffing issuesThe staffing requirements of a PET centre will vary depending on the type of centre (scanner

and cyclotron, or scanner alone) and also on whether the centre is predominantly clinical, or

both research and clinical. Whatever the service offered, there are issues relating to training for

all staff members. There are few trained clinicians, radiochemists, cyclotron engineers, physicists

and radiographers/medical technologists. Staff training in the UK needs to be addressed with

funding and the establishment of formal training courses. The funding may come partly from

the industry and partly from the government. A curriculum for medical training has been

established within the nuclear medicine training programme.

Findingsi The committee accepts that the accumulating evidence indicates that with regard to

patients with lung cancer, solitary pulmonary nodules and colorectal cancer and

lymphoma, the addition of PET is likely to be cost effective in their management.

i Evidence suggesting that PET will be beneficial in the management of patients with

other tumour types is accumulating.

i Currently PET is used in addition to other imaging techniques and in most cancers

FDG PET has a higher sensitivity than other forms of imaging.

i FDG PET is safe to perform.

i The method of imaging should be dedicated full-ring PET. The crystal type remains

to be evaluated and depends on recent developments with germanium

oxyorthosilicate (GSO) and lutetium oxyorthosilicate (LSO) rings. Most available data

uses bismuth germanate (BGO) systems.

i PET services performed using GCI should be discouraged. This should only be

reviewed:

– when these systems can demonstrate performance that is equivalent to or better

than the full-ring PET systems; or

– if their clinical utility can be demonstrated by adequate clinical studies to indicate

an incremental value to patient management compared with other imaging

methods.

i The establishment of clinical PET in the UK should be centrally controlled and

financed to allow the optimum provision of service throughout the UK whilst

maintaining a high clinical standard. A public-private partnership may be appropriate

for the provision of cyclotron facilities and tracer supply.

i The established cancer networks, cancer centres and appropriate tertiary referral

centres should provide the structure upon which the introduction of PET centres is

based. The exact siting of such centres will depend on the availability of tracer in the

short term, and the development of cyclotrons either by using or upgrading existing

facilities. There will be a need to develop new facilities particularly in those areas

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without access. These include the North East and South West of England, the central

corridor of Scotland and Northern Ireland.

RECOMMENDATIONS1 A national policy for the development of PET facilities should be established as soon

as possible.

2 State-of-the-art dedicated PET camera facilities should be established in at least

15 sites within the UK in the next 3–5 years, and in at least 40–60 sites in the next

10 years.

3 The majority of the initial sites should include cyclotron and radiotracer production

facilities or be sited where there are existing production facilities within two hours’

journey time.

4 Each cancer network should have access to a dedicated PET facility attached to a

radiotracer production facility. This is to enable the full range of PET tracers to be

available on at least one site within the network.

5 Cyclotron provision may be government funded, privately funded or a combination

of both. The cyclotrons should either be 10–13 or 13–18 MeV, depending on the

proposed size of the unit and the research potential.

6 PET scanners should be funded by the government, or a combination of private and

government funding. Operating costs should be included in the budgets of the cancer

networks and the cardiac and neurology services as appropriate.

7 Government funding is required in training programmes for PET radiochemists and

cyclotron engineers.

8 The number of trained personnel and the expense may be reduced by siting several

cameras on one site, providing patients have ready access to the facility.

PET imaging is developing rapidly elsewhere in the world. Health technology reviews performed

one or two years ago are already dated. The time is ripe to press on with providing an organised

national service for PET. This technology development should be regarded as a necessary part

of the NHS Plan and the NHS Cancer Plan.

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PART 1A strategy for the provisionof positron emissiontomography in the UK

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3

1 Introduction

1.1 Clinical positron emission tomography (PET) is now a reality. The transition from the

research environment, where it has been in use for over 25 years, to the clinical environment

has been made successfully over the last ten years. The major problem is that the UK has fallen

behind the rest of Europe and the USA in the provision of this service.3,4 The need for the service

will increase over the next five to ten years, particularly in relation to the management of patients

with malignancy such that a PET service is likely to be regarded as a mandatory part of staging

and restaging disease as well as monitoring therapy. It is therefore essential that the issue of the

provision of PET services is addressed. The NHS Plan has identified cancer, heart disease and

mental health as current clinical priorities.5 The NHS Cancer Plan outlines a series of objectives

aimed at reducing times from referral to diagnosis and appropriate treatment.6 PET has a role

in selecting patients for appropriate treatment, in diagnosis and in monitoring the patient’s

response to treatment. Decades of underinvestment in people and equipment have taken their

toll and it is possible this mistake will continue if the opportunity to develop clinical PET is not

taken.

Background1.2 PET is a nuclear medicine technology that uses short-lived radionuclides (carbon-11,

oxygen-15, nitrogen-13 and fluorine-18) attached to biological molecules to allow the

visualisation of metabolic processes in the body by producing an image of the distribution. Using

these tracers to visualise the biochemistry of a human, it is possible to view perturbations of the

system caused by disease processes such as cancer, coronary artery disease and neurological

disease. Biochemical or functional changes in the body often occur before any structural change,

so these functional images can show disease before anatomical images (computed tomography

(CT), magnetic resonance imaging (MRI) or ultra-sound scans (USS)) in some circumstances.

1.3 The most commonly used tracer is F-18 fluorodeoxyglucose (FDG) which allows the

examination of alterations in glucose metabolism which are known to occur in cancer cells. It

can also demonstrate abnormalities in areas of the body that use glucose preferentially as their

energy source, for example the brain and the myocardium. Other molecules which have a role

in evaluating disease (eg aminoacids, purines and pyrimidines as well as tracers that show blood

flow, hypoxia etc) can also be labelled. These short-lived radionuclides are made using cyclotrons

and then attached to the biological molecules using rapid chemistry techniques.

1.4 Clinical PET was introduced in the UK in 1992 through a self-funding unit based at Guy’s

and St Thomas’ Hospital. This unit has two dedicated PET cameras and is currently working at

capacity, accepting patients from around the UK. The use of PET, however, is now established

and its role becoming known to a wide variety of clinicians. There are three other clinical PET

imaging centres in the UK, two based in London, at University College London and Harley

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4

Street, and a further one at the Paul Strickland Scanner Centre at Mount Vernon Hospital in

Middlesex. There are also two research units in London, based at Imaging Research Solutions

Limited (IRSL, formerly the Medical Research Council Cyclotron Unit) at the Hammersmith

Hospital and the Functional Imaging Laboratory at Queen Square. Outside of London there are

the Wolfson Brain Imaging Centre at Addenbrooke’s Hospital in Cambridge, the Manchester

PET Centre at Christie Hospital and the PET Imaging Research Group at the University of

Aberdeen. These research units do not offer a comprehensive clinical scanning service, but some

do produce and distribute PET radiotracers. The above centres all have dedicated PET scanners.

There are also a number of other trusts that have acquired gamma camera coincidence imaging

(GCI), and these provide a limited PET service. The capabilities of such cameras are in their

infancy; whether they will mature remains to be seen, and their role is not established.3,4 The

technology is unlikely to have the same capabilities as dedicated PET and there may be other

drawbacks to providing a quality service. In line with clinical governance and evidence-based

practice this document considers the establishment of dedicated PET centres.

1.5 There are also private initiatives including mobile PET scanners, which may have a role in

the establishment of PET scanning in other regions of the country. Careful supervision would

be required to establish a quality service and the provision for adequate training of the reporting

clinicians. The costs of such an initiative would need to be explored with the private sector.

Similarly there are already commercial companies with expertise gained in the USA and Europe

who are establishing radiotracer production facilities in the UK.

1 Introduction

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5

2 Clinical PET: areas of use

2.1 There are three areas of use in the clinical arena. The largest area is within the field of

oncology, with cardiology and neuropsychiatry as the other predominant areas. A list of the

committee’s views on the current indications for PET are identified in Part 2 of this document.

The role of PET in oncology2.2 The principal role of PET in oncology can be thought of either in generic terms or in terms

of the systems affected by cancer.

Generic indications

2.3 The generic use of PET in the assessment of malignant disease can be summarised as:

i distinguishing benign from malignant disease, eg lung nodules, brain lesions etc;

i establishing the grade of malignancy, eg brain tumours, soft tissue masses;

i establishing the stage of disease, eg lung cancer, lymphoma;

i establishing whether there is recurrent or residual disease, eg lymphoma, teratoma,

seminoma;

i establishing the site of disease in the face of rising tumour markers, eg colorectal,

germ cell tumours;

i establishing the response to therapy before, during and after therapy imaging; and

i identifying the primary site of a tumour for biopsy either when site is unknown but

clinical indications are strongly pointing to a tumour (eg paraneoplastic syndrome)

or for therapeutic purposes.

Tumour-specific indications

2.4 PET is changing the way in which cancer is managed and is forcing a reassessment of

conventional staging with CT and MRI in certain cancer groups. It can be used to plan the

delivery of, and rapidly assess response to, therapy, allowing the treatment regimens to be

modified without delay if the response is inadequate. The largest influence of PET has been in

the management of lung tumours, colorectal tumours and lymphoma (see the appropriate

sections in the bibliography). The management of many other tumours is also affected. This is

evidenced by an increasing number of publications (particularly head and neck cancer

recurrence, testicular tumours, oesophageal cancer and melanoma (see bibliography)). These

roles although less well evaluated have been shown with anecdotal evidence to be beneficial to

patients.

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2 Clinical PET: areas of use

2.5 FDG PET has been shown to be cost effective in the assessment of pulmonary nodules and

in the staging of lung cancer. In the assessment of pulmonary nodules FDG PET has a reported

sensitivity of 82–100% and a specificity of 60–100%, with the majority of studies suggesting a

sensitivity of approximately 90% and a specificity of approximately 85%.7 The use of PET, either

in combination with CT or on its own, has been shown through the use of decision-tree modelling

to be cost effective. Ghambir et al demonstrated that a CT and PET strategy produced savings of

$1,154 per patient without loss of life expectancy.8 Dietlein et al showed that compared to a watch-

and-wait strategy the PET incremental cost-effectiveness ratio (ICER) was e3,218 per life year

saved, whereas if exploratory surgery were the norm then PET would be e6,912 per life year

saved.9 In lung cancer staging the sensitivity in the detection of metastatic disease has varied

between 66% and 100% with the majority of the literature suggesting 75% and the specificity

ranging between 80% and 100% with the majority in the region of 95%. Ghambir et al have

shown cost savings of between $91 and $2,200 per patient using both CT and PET to stage patients

with lung cancer.10 Dietlein et al showed that FDG PET was most cost effective in those patients

with normal sized mediastinal nodes on CT, with the ICER per life year saved costing only e143.11

Recently a prospective study has demonstrated the superiority of PET over CT in the assessment

of patients with lung cancer referred for surgery.1,2 Management changes have been observed in

20–60% of patients in various studies.2,12 These changes have been in both up- and down-staging

of patients; either promoting patients to surgery or preventing ineffective surgical intervention.

A recent randomised controlled study demonstrated that conventional workup and FDG PET

resulted in a 51% relative reduction in futile thoracotomy compared to conventional workup

alone.1 The use of FDG PET in radiotherapy treatment planning and for down-staging assessment

after chemotherapy is still to be evaluated. If PET is found to be valuable in these areas as well as

in surgical assessment then its role will expand within lung cancer.

2.6 Patients with recurrent colorectal carcinoma present a number of problems to the clinician.

Conventional imaging assessments have a poor record, with only 25% of patients with apparently

limited disease curable at surgery. With hepatic recurrence, over 50% are found to be unresectable

at surgery. A meta-analysis of the literature available on recurrent colorectal cancer demon-

strates an overall sensitivity of 97% (95% confidence levels 95–99%) and specificity of 76%

(95% confidence levels, 64–88%) for detecting disease sites, with management changes in 29%

(95% confidence levels of 25–34%) when FDG PET is used.13

2.7 CT is normally the modality used to stage lymphoma. FDG PET has been shown to change

management in anything up to 40% of patients who have already been staged with CT.

Furthermore, FDG PET appears to be useful in the assessment of residual masses found on CT.

The other potential area of use is in early assessment of disease response to chemotherapy, since

change of treatment regimes may be instigated earlier than normal if no response or a limited

response is observed following two cycles of therapy. This may have long-term benefits in the

reduction of second malignancies following initial chemotherapy.

2.8 The role of PET in other tumours cannot be underestimated. Significant evidence of utility

has been demonstrated, for example in the management of oesophageal cancer, soft tissue

sarcomas, testicular tumour recurrence (in residual masses or patients with rising markers),

metastatic melanoma and many other tumours. As of January 2001, health insurers in the USA

are funding FDG PET studies for solitary pulmonary nodules, staging of non-small cell lung

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2 Clinical PET: areas of use

cancer, lymphoma staging and restaging as well as recurrent colorectal tumours and recurrent

or metastatic melanoma. This list has expanded from its introduction in 1998, and in the USA

Centers for Medicare and Medicaid Services (CMS, previously known as the Health Care

Financing Administration or HCFA) proposed that ‘this science-based coverage decision provides

important expanded coverage of dedicated full-circular ring PET scanners and some partial-

ring systems for any clinically appropriate use for six types of cancer – lung, colorectal, lymphoma,

melanoma, oesophageal, and head and neck (but not brain or thyroid) cancer – and new coverage

of the neurologic and cardiac applications’. This list was further updated in November 2001 to

stipulate that most of these indications were for full-ring or partial-ring PET cameras.

The role of PET in cardiology and cardiac surgery2.9 The major role for PET imaging in this area is to establish whether there is sufficient viable

myocardium in a patient with poor ventricular function to justify attempts at revascularisation.

The predictive ability for contractile recovery is approximately 80% positive predictive value of

mismatched perfusion and FDG uptake, and 85% negative predictive value for matched reduction

in perfusion and FDG uptake. The other potential use is in patients with severe ischaemic

cardiomyopathy who are being considered for cardiac transplantation. A survival benefit has

been shown to be present in those that had mismatched perfusion and FDG, and underwent

revascularisation, compared with those that had no mismatch and underwent medical treatment.

Those patients who had no mismatch and underwent cardiac transplantation also had improved

survival. Furthermore, the accuracy of PET for the detection of coronary artery disease is highly

sensitive and specific of the order 82–100%. The indications would appear to be:

i diagnosis of hibernating myocardium in patients with poor left ventricular function

prior to revascularisation procedure;

i distinguishing ischaemic from non-ischaemic cardiomyopathy;

i identifying patients with a fixed single photon emission computed tomography

(SPECT) deficit who might benefit from revascularisation; and

i use prior to referral for cardiac transplantation.

The role of PET in neurology and neuropsychiatry2.10 The principal applications for PET in neurology are for the pre-surgical workup of patients

with partial epilepsy, assessment of dementias, and diagnosis and detection of recurrent primary

brain tumours. The sensitivity and specificity for unilateral hypometabolism in temporal lobe

epilepsy are approximately 70–85% and 86% respectively. The role in dementia imaging is at

present limited, since although it has a high sensitivity and diagnostic accuracy is not a great

deal better than single photon emission tomography (SPET) imaging techniques.

Cost effectiveness2.11 There have been a number of reports by a variety of health technology assessments including,

most recently, the Commonwealth report on PET,14 the United States Veterans Affairs Management

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2 Clinical PET: areas of use

Decision and Research Center (MDRC) Technology Assessment Program in 1996 and 1998,15,16

and the United Kingdom National Coordinating Centre for Health Technology Assessment

(NCCHTA).17 These reports all have their problems, not least the fact that they are now out of

date and using literature that is at least two years old, and in some cases six or seven years old.

The NCCHTA report had a number of other problems, particularly the Delphi study in which

questions were asked of researchers or specialists who were hoping to generate funding for

equipment and research. The areas of assessment of the technology raised in the report by Roberts

and Milne are likely to be superseded since there is broad agreement that the GCI technology is

inferior to dedicated PET cameras. Similarly, prospective studies have been performed in real

clinical situations demonstrating the added value of dedicated PET over conventional CT imaging

in lung cancer. Peter Valk has eloquently argued that randomised controlled trials are not

appropriate for assessing imaging methods, and the use of modelling sensitivity and specificity

data to assess the likely cost effectiveness is a more rapid way of providing such information, and

one which does so in a way that can be applied to each country’s health circumstances.18 It is also

of interest that the most recent review of PET in the Commonwealth document still used these

dated HTA reports, and despite reaching the conclusion that there is little cost-effectiveness data

available the report suggested that PET has a role in:

i differentiation of malignant from benign lesions in patients with a solitary

pulmonary nodule;

i primary staging in patients with non-small cell lung cancer (NSCLC);

i primary staging in patients with suspected primary brain tumour;

i evaluation of residual structural lesions after definitive therapy for colorectal cancer

(CRC);

i evaluation of residual structural lesions after definitive therapy for recurrent glioma;

i pre-operative assessment of metastatic disease in CRC;

i pre-operative assessment of apparently limited metastatic disease in malignant

melanoma;

i localisation of epilepsy; and

i assessment of ischaemic heart disease.

2.12 The economic modelling has been performed in different health care settings and suggests

that PET is cost effective, or even cost saving, based on the assumptions made. Whether PET affects

long-term outcome remains to be fully tested in malignant conditions, however it is clear that it

can affect the short-term management of patients with cancer. Outcome effects may take up to

20 years to evaluate; for example, whether changes in chemotherapy or radiotherapy regimens early

in the course of disease treatment will reduce the occurrence of second cancers. If an imaging

modality is superior to another imaging modality and provides different information allowing

management changes, we should not wait a further 5–10 years to show long-term outcome effects;

these changes have been modelled and prospective studies are showing these models to be true.

Furthermore, the human costs of delay in the introduction of this modality may be large, since the

management changes demonstrated suggest that unnecessary surgery can be avoided and necessary

surgery expedited. There is consequently the potential to enable the appropriate treatment pathway.

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9

3 The requirements of a national PET service

3.1 The major use of clinical PET is in oncology as discussed above. The recent publication of

health statistics shows the number of cases of cancer in England and Wales.19 If the major cases

of cancer are considered and compared with the current identified role of PET then the potential

patient base can be identified. The number of new cases of cancer identified in 1994 was 224,320.

The major cancers in men were lung, colorectal and prostate and in women they were lung,

colorectal and breast. These tumour types constituted over half the registrations. For lung cancer

and colorectal cancer there is meta-analysis evidence of the utility of PET. There is emerging

evidence of probable use in breast cancer. Furthermore the cancer statistics for 1997 show over

6,000 new cases of oesophageal cancer, 1,400 cases of testicular cancer, 3,500 cases of brain

tumour and 7,200 cases of non-Hodgkin’s lymphoma, 5,500 cases of lip, mouth and larynx

cancer and 4,600 cases of melanoma in 1997.19 All of these tumour groups would benefit from

PET examinations for staging and treatment response assessments. The prevalence of patients

with cancer on the 1 January 1993 was almost 650,000. The patients who are still alive and have

had cancer will be under surveillance and so may also contribute to the demand for PET (since

a large portion of these will have colorectal cancer where the evidence for the role of PET scanning

in the detection of recurrent disease is robust). The registration of new cancers for 1995–7 is

very similar to the numbers for 1994 with 219,700 noted.

3.2 The statistics quoted can also be portrayed as new cases per million of the population.

These figures show an overall cancer incidence of 8,690 p.a. per million with over half of these

falling into groups where there is robust evidence of the benefits of clinical PET with the currently

available tracer, FDG. Assuming the role of PET is confined to the tumour groups with either

meta-analysis evidence or robust clinical data supporting its use, the new lung cancer cases are

presently 1,390 p.a. per million, colorectal disease 1,120 p.a. per million and lymphoma cases

280 p.a. per million. Assuming that 15% of lung cancers are considered operable and a further

10% may be downstaged by chemotherapy, then PET has a potential role in approximately 25%

of lung cancers, that is 208–347 p.a. per million of the population. Similarly for the colorectal

cancers with this sort of incidence the prevalence of cases for assessment of residual or recurrent

disease is likely to be 250 p.a. per million of the population. All lymphomas would benefit from

staging with PET scanning in addition to either interim assessment during chemotherapy or

post chemotherapy. Therefore within a population of a million a conservative estimate of the

number of patients who would directly benefit from PET scans each year is 730. Other tumour

types will also benefit under a variety of circumstances. Perhaps a more realistic estimate can be

obtained by projecting that about 15–20% of the 8,000 patients p.a. per million of the population

with cancer would benefit from PET imaging; this would amount to approximately 1,600 patients

each year.

3.3 A dedicated clinical PET centre could be justified serving a population of 1–1.5 million

people. This is approximately the number of people subserved by the current cancer centres.

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Some of these PET centres would enable investigation of the other conditions for which PET

can contribute to the treatment within cardiology and neurology. This would be particularly

true if the PET facility was in a tertiary referral centre with a high workload in these areas.

Equipment and personnel3.4 An editorial in Lancet has addressed the issue with regard to the equipment currently

available and becoming available.4 The staffing issues will ultimately depend on the mix of clinical

service provision and research and development undertaken by a centre. The presence of an on-

site cyclotron would generally need a larger than normal scanning staff in addition to the

production staff, due to the ability of the centre to perform more complex studies using a variety

of shorter half-life radiotracers. Staffing of a clinical PET centre depends on the number of PET

cameras and the variety and volume of work undertaken. A model can be established for a

scanning facility supplied with fluorine-based radiotracers from a distant production facility.

The work is likely to be less complex and may start later in the day.

3.5 For each of these models, costs for providing a service can be divided into fixed and variable

costs. The costs for a centre which provides an imaging service with a distant supply of tracer

are:

Capital costs: £1,285,050

Operating costs: £585,900 p.a.

The costs for a centre which undertakes imaging and full production are:

Capital costs: £2,761,750

Operating costs: £670,850 p.a.

These figures are discussed in more detail in the appendices.

10

3 The requirements of a national PET service

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11

4 Current problems and their solutions

Problems with service provision

Staffing

4.1 The problem with staffing PET units is that there is at present a shortage of suitably trained

and experienced staff at all levels. Providing a full scanning service with radiotracer production

requires a multidisciplinary team of scientific, medical, technical and support staff. The pressure

of dealing with short half-life radiotracers can at times be challenging and requires flexibility,

precision, commitment and the ability to work to stringent time pressures. Staff at a scanning

site which is remote from the production facility can be subject to delays and the occasional

production failure; this can be frustrating and disruptive to the working day.

Training issues

4.2 There are training issues associated with all the disciplines involved in PET scanning. There

is a need to establish a comprehensive training programme. There are few trained PET

radiochemists or cyclotron engineers/technicians in the world, let alone the UK. Training may

be undertaken by private companies with experience in providing radiotracer production

facilities. However it may also be provided through MSc courses, or vocational training on an

approved university course which is sponsored by industry or the government. This needs to be

established as a matter of urgency. Similarly there are few trained cyclotron engineers/technicians,

but other disciplines such as radiotherapy workshop technologists do have some of the skills,

which, with the appropriate training, could provide necessary trouble-shooting and first-line

maintenance. Formal training and on-the-job experience is required for these key members of

the production team. The current difficulties in recruiting nuclear medicine technologists and

radiographers for general departments are exacerbated when attempting to recruit for PET

centres. Experienced, trained staff are not readily available in the UK and training needs to be

given on site. BSc courses now include some PET lectures and an annual course is now offered

by Guy’s and St Thomas’ PET Centre, but on-the-job training is required. Arranging rotations

or split posts with other cross-sectional imaging departments (such as CT or MRI) may make

these positions more attractive to radiographers who have not trained in nuclear medicine. There

are few trained PET clinicians. Training for clinicians is being addressed by including PET as

part of the Certificate of Completion of Specialist Training (CCST) in nuclear medicine, but

post-CCST experience is also required. Post-CCST modular training would also be appropriate

for radionuclide radiologists but there is no mechanism to validate such training. There are few

centres in the UK where this experience can be gained and consequently it has been necessary

for clinicians to gain on-the-job experience or to spend short periods in non-UK centres. This

will be a significant issue in the clinical staffing of PET centres.

4.3 The delivery and maintenance of the service needs to be consistent with the Ionising

Radiation (Medical Exposure) Regulations 200020 and the relevant aspects of Ionising Radiations

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12

4 Current problems and their solutions

Regulations 1999,21 and the Administration of Radioactive Substances Advisory Committee

(ARSAC).22 It also needs to comply with necessary standards of delivery of a high quality service

as well as issues related to clinical governance.

Problems with establishing PET in the UK4.4 Currently there are few centres in the UK with PET scanning, and even fewer radiotracer

production sites. There needs to be a large capital investment programme covering all regions

of the UK to establish the technique and provide a service, especially for cancer patients. There

is a golden opportunity at this time for the government to identify strategic geographical sites

for the establishment of radiotracer production facilities and a subsequent positioning of

scanning units. There are currently cyclotrons at St Thomas’ Hospital, Imaging Research

Solutions Limited (IRSL) at the Hammersmith Hospital, the Wolfson Brain Imaging Centre at

Addenbrooke’s Hospital Cambridge, Mount Vernon Hospital, and the PET Imaging Research

Group at the University of Aberdeen. The cyclotron at Clatterbridge produces F-18 for FDG

production at the Manchester PET Centre at the Christie Hospital. There is also a large cyclotron

in Birmingham which could possibly be adapted to produce radiotracers for PET scanning.

These centres could provide the starting point for a network of PET radiotracer production

facilities, with PET scanning units being established within two to four hours’ travel from those

sited in cancer centres. This has the advantage that the major capital outlay on cyclotrons and

radiotracer production facilities could be deferred whilst ensuring access for a larger number of

patients to PET scanning. Consideration should be given to funding for a cyclotron and

production facilities associated with cancer centres and nuclear medicine facilities in the north

east and south west of England and the central corridor of Scotland. This would establish a unit

in regions of the country where access would otherwise be difficult and would involve travelling

to London.

4.5 While these developments are occurring, staff could be trained in existing clinical PET

institutions providing funding can be found.

i The training of staff needs to be addressed with government support for training programmes,

especially for the scientific staff.

i For medical trainees the training has been addressed in the new curriculum of the RCP for the

CCST in nuclear medicine.

i Radiographers should be encouraged to embrace PET scanning as an additional skill, perhaps linking

it with CT and MRI training to provide combined jobs in the future.

BOX 1 Action on staffing

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13

5 Suggested strategy for the provision of a PET service

5.1 There is a proposal to develop approximately 37 cancer networks in England and Wales.

These could form the basis for the provision of a high quality PET service. If Scotland and

Northern Ireland follow the same model, it could be developed to cover the whole of the UK.

There are currently around 60 cancer centres in the UK and even more cancer units. All cancer

centres should have access to the full range of nuclear medicine services, and therefore have the

services of one or more specialists in nuclear medicine.23

5.2 The case has been made in this document for a PET service to supply a population of about

one million people. This number of people will allow a single camera facility to be utilised full-

time, providing enough patients to maintain the throughput necessary to ensure the need for a

high quality service and maintenance of clinical skills. Larger cancer centres which deal with a

greater variety of tumours and provide advances in therapy would almost certainly need an

additional camera to allow research and development alongside the monitoring of therapy. The

introduction of PET can be phased in around the country, but individual trusts would need

financial support to introduce a service and maintain it. An initial investment to provide a service

in 15 areas of the country should be considered, along with the establishment of a PET radiotracer

production facility in the North East and South West of England, the central corridor of Scotland,

and Northern Ireland. There should then be a second phase introducing further scanners, either

at new or established sites.

5.3 The expenditure on dual coincidence imaging should be curtailed. Even if the dual

coincidence GCI has a limited role it will not compete with dedicated PET, and the previously

quoted statement from the HCFA in the USA suggests that full-ring systems are the method they

are willing to finance. Both technologies are advancing and the likelihood is that dedicated PET

systems will have a high patient throughput in the next few years because of the advances in

crystal design and nature, and the electronics of the cameras, which will allow larger numbers

of patients to be scanned. The clinical utility is proven with dedicated PET and has yet to be

proven with GCI. The UK has a history of not funding the optimum methods of imaging until

much later than is necessary. There should be no delay in funding this imaging method with the

optimum equipment.

5.4 The resource of PET has to be embraced as a national strategy to give patients the full

benefit of the technology. Therefore a controlled introduction, judiciously positioned, needs to

be considered. It will need to be funded either separately by the Government (both the capital

outlay and the running of the service), or by private investment. This latter strategy is beyond

the scope of this paper.

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5.5 Macintyre et al recently discussed the use of evidence to inform health policy.24 The criteria

suggested for use in the evaluation of policy recommendations have been applied to PET as

follows:

1 Support by systematic evidence, empirical evidence. There is a wealth of data

establishing the role of dedicated PET in oncology, and other data to support its role

in specific areas of cardiology and neuropsychiatry (see bibliography). Accompanying

these publications have been meta-analyses of the available data supporting the use in

colorectal recurrence, lung malignancies and so on, and cost-effectiveness analyses

supporting the use of PET in solitary pulmonary nodules and the staging of

pulmonary malignancies.

2 Support by cogent argument. The case for development of a PET network

throughout the UK is presented above.

3 Scale of likely health benefits. The cost-effectiveness data for lung cancer points the

way to further cost-effectiveness studies which need to be performed. There is,

however, substantial published evidence which demonstrates the effect on

management of patients such that the US health insurers have accepted the role of

PET in areas outlined above.

4 Likelihood that policy would bring benefits other than health benefits. Benefits

would be in terms of employment of skilled personnel and contribution to research.

5 Compatibility with existing or proposed government strategy. The proposed

introduction of PET facilities coincides with the government strategy on improving

the management of patients with cancer and cardiac disorders.

6 Possibility that the policy might do harm. The introduction of a number of PET

centres is unlikely to do harm. It is important to avoid the introduction of a system

where the centres are not run by trained personnel and where misdiagnosis is

therefore a potential problem.

7 Ease of implementation. The strategy would be possible to implement if the

distribution of centres was determined by a central government edict. The siting of

cyclotrons could be evaluated, depending on the populations to be subserved,

transport links and the skills available. PET scanners could be installed through a

rolling programme, initially in centres with access to existing cyclotrons and then

14

5 Suggested strategy for the provision of a PET service

i The currently available clinical cyclotrons should be invested in to ensure they are capable of

producing tracer for other units.

i The sites for clinical PET centres should be identified as a first phase for new scanners.

i PET should be associated with cancer centres, or at the least cancer networks.

i Private sector funding should be assessed.

BOX 2 Action on the provision of a national PET service

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rolled out when further cyclotrons are installed. Over this period funding for training

individuals (as outlined above) would need to be started and trainees encouraged to

take up posts.

8 Cost of implementation. PET is an expensive technology and therefore needs to be

implemented in several phases and over many years. If an initial 10–15 centres were

established around the UK an assessment could be made over one or two years as to

the ultimate requirement. This is likely to be between 40 and 60 centres with between

one and three scanners per centre.

15

5 Suggested strategy for the provision of a PET service

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6 Conclusion

6.1 The establishment of clinical PET in the UK should be controlled and financed centrally

to allow the optimum provision of service throughout the UK whilst maintaining a high clinical

standard.

6.2 The established cancer networks and cancer centres should provide the structure upon

which the introduction of PET centres is based. The exact siting of the centres will depend on

the availability of tracer in the short term, and the development of radiotracer production

facilities around the country. These facilities already exist in certain areas and the feasibility of

them providing tracer or being upgraded to increase tracer production needs to be investigated.

The areas of the country which are without access include the North East and South West of

England, the central corridor of Scotland and Northern Ireland, and investment in cyclotrons

may need to be provided to establish these areas.

16

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PART 2Clinical indications forpositron emissiontomography imaging:current ICSCNMsuggestions

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Introduction

Positron emission tomography (PET) scanning is now available in the UK as a diagnostic imaging

modality. This rapidly developing technique has been shown to be clinically useful in a range of

specialties, and further assessment of its role in patient management is under way in a number

of clinical studies worldwide. Although PET scanning is sometimes thought of as a separate and

unique imaging specialty (like MRI) it should be regarded as an extension of nuclear medicine

using specific radiopharmaceuticals (positron-labelled tracers) and a specialised detecting system

optimised for the detection of the 511 KeV coincidence photons.

It is not possible at the current time to be dogmatic about the role of PET imaging in clinical

medicine, partly because of the limited facility for PET imaging in the UK. However, based on

clinical experience, coupled with the published data, there are now many clinical situations where

it is the imaging method of choice. There will always be situations when more than one diagnostic

technique can be used to provide similar although less accurate information and the choice will

often depend on factors such as availability, cost, skills etc.

The common radiotracers used are FDG (F-18 Fluorodeoxyglucose), methionine (C-11

methionine), ammonia (N-13 ammonia), water (O-15 water) and flumazenil (C-11 flumazenil).

Radiation hazardsThe radiation dose to the patient, associated with PET investigations, will depend on the tracer

used and the activity administered (Table 1).

Radiation doses received by accompanying persons are low because of the short half-lives of the

tracers currently used. The doses to adults are below the current European recommended levels.

19

Table 1 Typical radiation doses for current practice. The administration of activity for paediatricstudies are scaled down by the body weight as a proportion of a 70kg adult dose.

Radionuclide Radiopharmaceutical Injected Target organ Whole body activity (MBq) dose (mSv)

Carbon-11 Methionine 370–740 Pancreas 1.7–3.4

Flumazenil 370 Small intestine 1.32

Fluorine Fluorodeoxyglucose 250–400 Bladder 6.8–10

Fluoride 222 Bladder 6.0

Nitrogen-13 Ammonia 550 Bladder 1.5

Oxygen-15 Water 2,300 Ovaries (female) 2.7Large intestine (male)

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Children should not accompany parents who are having a PET scan, since close contact

immediately following tracer administration will result in higher received radiation doses. The

radiation dose rates are low when contact is resumed two hours after the injection.25

Breast feedingThe patient is encouraged to express the next feed after the scan but does not need to reduce

contact with children given the current injected activity of 350–400 MBq of FDG. Breast feeding

may then be restarted normally. Whilst this advice applies to one-off exposures, patients who

are likely to receive a number of PET or nuclear medicine scans may be advised to reduce close

contact with small children for a longer period.

Pregnancy and protection of the foetusIrradiation of a foetus is to be avoided whenever possible. If the scan is judged clinically essential

then discussion with the patient with regard to the radiation dose and the risks associated with

not performing the investigation should be undertaken.

The clinical indications tableThe following table is divided into the four clinical sections which cover the main areas of PET

imaging: oncology, cardiology, neuropsychiatry and miscellaneous applications. For each of

these sections the indications will be classified into ‘indicated’, ‘not routinely indicated (but may

be helpful)’, and ‘not indicated’.

The strength of the evidence for the various indications is identified using the NHS Executive

clinical guidelines.26 This system of definitions is used in the Making the best use of a department

of clinical radiology booklet published by the Royal College of Radiologists.

The strength of evidence is classified as:

A. Randomised controlled clinical trials, meta-analyses, systematic reviews.

B. Robust experimental or observational studies.

C. Other evidence where the advice relies on expert opinion and has the endorsement of

respected authorities.

Note about oncology applications

Applications in oncology can be considered under a number of headings, which have different

importance in different tumours. Areas of use may be considered by generic guidance or by the

pathological system affected. The generic guidance considers the management issues for oncology

patients. The list in paragraph 2.3 of Part 1 relates generally to all malignancies and forms a basis

for which PET examinations may be useful. Indications organised by the pathological system

affected are given in the table below.

20

Clinical indications

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21

Clinical indications

Brai

n an

d sp

inal

cor

di

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d tu

mou

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whe

n i

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22

Clinical indications

Para

thyr

oid

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reat

ed c

ance

rs. (

C)

Stom

ach

iN

o ro

utin

e in

dica

tion.

(C

)i

Ass

essm

ent

of g

astr

o-oe

soph

agea

l mal

igna

ncy

and

loca

l m

etas

tase

s. (

C)

Smal

l bow

eli

No

rout

ine

indi

catio

n. (

C)

iPr

oven

sm

all b

owel

lym

phom

a to

ass

ess

exte

nt o

f di

seas

e. (

C)

Brea

st c

ance

ri

Ass

essm

ent

and

loca

lisat

ion

of b

rach

ial p

lexu

s i

Axi

llary

nod

e st

atus

whe

re t

here

is a

rel

ativ

e i

Rou

tine

asse

ssm

ent

of p

rim

ary

brea

st c

ance

r. (

C)

lesi

ons

in b

reas

t ca

ncer

. (R

adia

tion

effe

cts

vers

us

cont

rain

dica

tion

to a

xilla

ry d

isse

ctio

n. (

C)

mal

igna

nt in

filtr

atio

n.)

(C)

iA

sses

smen

t of

mul

tifoc

al d

isea

se w

ithin

the

diff

icul

t i

Ass

essm

ent

of t

he e

xten

t of

dis

sem

inat

ed

brea

st (

dens

e br

east

or

equi

voca

l rad

iolo

gy).

(C)

brea

st c

ance

r. (

C)

iSu

spec

ted

loca

l rec

urre

nce.

(C

)i

Ass

essm

ent

of c

hem

othe

rapy

res

pons

e. (

C)

Live

r: p

rim

ary

lesi

oni

Rou

tine

asse

ssm

ent

of h

epat

oma.

(C

)

Indi

cate

dN

ot

indi

cate

d ro

utin

ely

(but

may

be

help

ful)

No

t in

dica

ted

cont

inue

d

Page 30: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

23

Clinical indications

Live

r: s

econ

dary

lesi

oni

Equi

voca

l dia

gnos

tic im

agin

g (C

T, M

RI,

ultr

asou

nd).

(C)

iA

sses

smen

t pr

e an

d po

st t

hera

py in

terv

entio

n. (

C)

iEx

clud

e ot

her

met

asta

tic d

isea

se p

rior

to

met

aste

ctom

y. (

C)

Panc

reas

iSt

agin

g a

know

n pr

imar

y. (

C)

iD

iffer

entia

tion

of c

hron

ic p

ancr

eatit

is fr

om p

ancr

eatic

ca

rcin

oma.

(C

)i

Ass

essm

ent

of p

ancr

eatic

mas

ses

to d

eter

min

e be

nign

or

mal

igna

nt s

tatu

s. (

C)

Col

on a

nd r

ectu

mi

Ass

essm

ent

of r

ecur

rent

dis

ease

. (A

)i

Ass

essm

ent

of t

umou

r re

spon

se. (

C)

iA

sses

smen

t of

pol

yps.

(C

)i

Prio

r to

met

aste

ctom

y fo

r co

lore

ctal

can

cer.

(C

)i

Ass

essm

ent

of a

mas

s th

at is

diff

icul

t to

bio

psy.

(C

)i

Stag

ing

a kn

own

prim

ary.

(C

)

Ren

al a

nd a

dren

ali

Ass

essm

ent

of p

ossi

ble

adre

nal m

etas

tase

s. (

C)

iPa

raga

nglio

nom

as o

r m

etas

tatic

pha

eoch

rom

ocyt

oma

iA

sses

smen

t of

ren

al c

arci

nom

a. (

C)

to id

entif

y si

tes

of d

isea

se. (

C)

iPh

aeoc

hrom

ocyt

oma

– M

IBG

sca

nnin

g is

usu

ally

su

peri

or. (

C)

Blad

der

iN

o ro

utin

e in

dica

tion.

(C

)i

Stag

ing

a kn

own

prim

ary

in s

elec

ted

case

s. (

C)

iR

ecur

renc

e w

ith e

quiv

ocal

imag

ing.

(C

)

Pros

tate

iFD

G in

pro

stat

e ca

ncer

ass

essm

ent.

(C)

Tes

ticle

iA

sses

smen

t of

rec

urre

nt d

isea

se fr

om

iA

sses

smen

t of

pri

mar

y tu

mou

r st

agin

g. (

C)

sem

inom

as a

nd t

erat

omas

. (B)

iA

sses

smen

t of

res

idua

l mas

ses.

(B)

Ova

ryi

In d

iffic

ult

man

agem

ent

situ

atio

ns t

o as

sess

loca

l an

d di

stan

t sp

read

(C

)

Ute

rus:

cer

vix

iN

o ro

utin

e in

dica

tion.

(C

)i

In d

iffic

ult

situ

atio

ns t

o de

fine

the

exte

nt o

f dis

ease

w

ith a

ccom

pany

ing

imag

e re

gist

ratio

n. (

C)

Indi

cate

dN

ot

indi

cate

d ro

utin

ely

(but

may

be

help

ful)

No

t in

dica

ted

cont

inue

d

Page 31: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

24

Clinical indications

Ute

rus:

bod

yi

No

rout

ine

indi

catio

n. (

C)

Lym

phom

ai

Stag

ing

of H

odgk

in’s

lym

phom

a. (

B)i

Ass

essm

ent

of b

owel

lym

phom

a. (

C)

iSt

agin

g of

non

-Hod

gkin

’s ly

mph

oma.

(B)

iA

sses

smen

t of

bon

e m

arro

w t

o gu

ide

biop

sy. (

C)

iA

sses

smen

t of

res

idua

l mas

ses

for

activ

e i

Ass

essm

ent

of r

emis

sion

from

lym

phom

a. (

C)

dise

ase.

(B)

iId

entif

icat

ion

of d

isea

se s

ites

whe

n th

ere

is

susp

icio

n of

rel

apse

from

clin

ical

ass

essm

ent.

(C)

iR

espo

nse

to c

hem

othe

rapy

. (C

)

Mus

culo

skel

etal

tum

ours

iSo

ft t

issu

e pr

imar

y m

ass

asse

ssm

ent

to

iIm

age

regi

stra

tion

of t

he p

rim

ary

mas

s to

iden

tify

dist

ingu

ish

high

gra

de m

alig

nanc

y fr

om lo

w o

r op

timum

bio

psy

site

. (C

)be

nign

dis

ease

. (B)

iSt

agin

g of

pri

mar

y so

ft t

issu

e m

alig

nanc

y to

as

sess

non

skel

etal

met

asta

ses.

(B)

iA

sses

smen

t of

rec

urre

nt a

bnor

mal

ities

in

oper

ativ

e si

tes.

(B)

iA

sses

smen

t of

ost

eoge

nic

sarc

omas

for

met

asta

tic d

isea

se. (

C)

iFo

llow

up

to d

etec

t re

curr

ence

or

met

asta

ses.

(B)

Skin

tum

ours

iM

alig

nant

mel

anom

a w

ith k

now

n di

ssem

inat

ion

iSt

agin

g of

ski

n ly

mph

omas

. (C

)i

Mal

igna

nt m

elan

oma

with

neg

ativ

e se

ntin

el n

ode

to a

sses

s ex

tent

of d

isea

se. (

B)bi

opsy

. (B)

iM

alig

nant

mel

anom

a in

who

m a

sen

tinel

nod

e bi

opsy

was

not

or

can

not

be p

erfo

rmed

in s

tage

II.

(AJC

C u

pdat

ed c

lass

ifica

tion)

. (C

)

Met

asta

ses

from

i

Det

erm

inin

g th

e si

te o

f an

unkn

own

prim

ary

iW

ides

prea

d m

etas

tatic

dis

ease

whe

n th

e un

know

n pr

imar

yw

hen

this

influ

ence

s m

anag

emen

t. (C

)de

term

inat

ion

of t

he s

ite is

onl

y of

inte

rest

. (C

)

Indi

cate

dN

ot

indi

cate

d ro

utin

ely

(but

may

be

help

ful)

No

t in

dica

ted

cont

inue

d

Page 32: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

25

Clinical indications

iD

iagn

osis

of h

iber

natin

g m

yoca

rdiu

m in

i

Dia

gnos

is o

f cor

onar

y ar

tery

dis

ease

or

asse

ssm

ent

of

iPa

tient

s w

ith c

onfir

med

cor

onar

y ar

tery

dis

ease

pa

tient

s w

ith p

oor

left

ven

tric

ular

func

tion

prio

r kn

own

coro

nary

ste

nosi

s w

here

oth

er in

vest

igat

ions

. in

who

m r

evas

cula

risa

tion

is n

ot c

onte

mpl

ated

or

to r

evas

cula

risa

tion

proc

edur

e. (

A)

(SPE

CT

, EC

G e

tc)

rem

ain

equi

voca

l. (B

)in

dica

ted.

(C

)i

Patie

nts

with

a fi

xed

SPET

def

icit

who

mig

ht

iD

iffer

entia

l dia

gnos

is o

f car

diom

yopa

thy

(isch

aem

ic

iR

outin

e sc

reen

ing

for

coro

nary

art

ery

dise

ase.

be

nefit

from

rev

ascu

lari

satio

n. (

B)ve

rsus

oth

er t

ypes

of d

ilate

d ca

rdio

myo

path

y). (

C)

(C)

iPr

ior

to r

efer

ral f

or c

ardi

ac t

rans

plan

tatio

n. (

B)i

Med

ical

tre

atm

ent

of is

chae

mic

hea

rt d

isea

se in

hig

h ri

sk h

yper

lipid

emic

pat

ient

s. (

C)

Neu

rops

ychi

atry

app

licat

ions

iPr

esur

gica

l eva

luat

ion

of e

pile

psy.

(B)

iT

he g

radi

ng o

f pri

mar

y br

ain

tum

our.

(B)

iD

iagn

osis

of d

emen

tia w

here

MR

I is

clea

rly

iSu

spec

ted

recu

rren

ce o

r fa

iled

prim

ary

iLo

calis

atio

n of

opt

imal

bio

psy

site

(ei

ther

pri

mar

y or

ab

norm

al. (

C)

trea

tmen

t of

pri

mar

y m

alig

nant

bra

in t

umou

rs.

recu

rren

t br

ain

tum

our)

. (C

)i

Mos

t in

stan

ces

of s

trok

e. (

C)

(Mos

t of

the

se p

atie

nts

will

hav

e ha

d M

RI a

nd C

T

iD

iffer

entia

ting

mal

igna

ncy

from

infe

ctio

n in

HIV

sub

ject

s i

Mos

t ps

ychi

atri

c di

sord

ers

othe

r th

an e

arly

w

ith e

quiv

ocal

res

ults

). (B

)w

here

MR

I is

equi

voca

l. (C

)de

men

tia. (

C)

iEa

rly

diag

nosi

s of

dem

entia

(es

peci

ally

you

nger

i

Pre-

sym

ptom

atic

or

at r

isk

Hun

tingd

on’s

pa

tient

s an

d A

lzhe

imer

’s d

isea

se)

whe

n M

RI o

r C

T

dise

ase.

(C

)is

eith

er n

orm

al, m

argi

nally

abn

orm

al o

r i

Dia

gnos

is o

f epi

leps

y. (

C)

equi

voca

lly a

bnor

mal

. (B)

Mis

cella

neo

us a

pplic

atio

ns

Dis

ease

ass

essm

ent

in

iId

entif

icat

ion

of s

ites

to b

iops

y in

pat

ient

s w

ith

iR

outin

e as

sess

men

t of

wei

ght

loss

whe

re m

alig

nanc

y is

H

IV a

nd o

ther

py

rexi

a. (

C)

susp

ecte

d. (

C)

imm

unos

uppr

esse

d i

Diff

eren

tiatin

g be

nign

from

mal

igna

nt c

ereb

ral

patie

nts

path

olog

y. (

B)

Ass

essm

ent

of b

one

iA

sses

smen

t of

bon

e in

fect

ion

asso

ciat

ed w

ith

infe

ctio

npr

osth

eses

. (C

)i

Ass

essm

ent

of s

pina

l inf

ectio

n or

pro

blem

atic

cas

es o

f in

fect

ion.

(C

)

Indi

cate

dN

ot

indi

cate

d ro

utin

ely

(but

may

be

help

ful)

No

t in

dica

ted

Car

diac

app

licat

ions

cont

inue

d

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26

Clinical indications

Ass

essm

ent

of b

one

iW

hen

bone

sca

n or

oth

er im

agin

g is

equ

ivoc

al. (

C)

met

asta

ses

Ass

essm

ent

of t

umou

r i

Iden

tifyi

ng r

ecur

rent

func

tiona

l pitu

itary

tum

ours

whe

n re

curr

ence

in t

he

anat

omic

al im

agin

g ha

s no

t be

en s

ucce

ssfu

l. (C

)pi

tuita

ry

Feve

r of

unk

now

n i

Iden

tifyi

ng s

ourc

e of

the

feve

r of

unk

now

n or

igin

. (C

)or

igin

Indi

cate

dN

ot

indi

cate

d ro

utin

ely

(but

may

be

help

ful)

No

t in

dica

ted

Page 34: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

APPENDICES

Page 35: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

APPENDIX 1Imaging with a distant supply of tracer : theminimum establishment*

Capital costsCapital costs include the PET scanner, associated computer workstations and network equipment

in addition to data storage media. A full resuscitation trolley, a pulse oximeter and blood glucose

monitoring equipment for the scan room are included, as well as radiation protection and

monitoring equipment. An allocation for basic office equipment and furniture is also listed.

Building and space renovation costs have not been included.

Operating costsIt has been assumed that this facility would scan in the region of 1,000 patients per year. This

assumes an average throughput of four patients per day if scanning is said to be five days per

week for 48 weeks of the year with allowance made for maintenance, breakdown and bank

holidays. London weighting and on-costs are included. It is assumed that the facility will be

managed from an associated nuclear medicine or radiology department.

Staff costs

Two to three radiographers/nuclear medicine technologists would be required to perform

radiotracer administration, patient scanning and image processing. The support of one WTE

medical physicist would be necessary to provide cover for data processing, scanner quality control

and the on-going development of image acquisition and processing protocols and radiation

protection. The receptionist/secretary is required to book scans, send out appointments, type

29

Capital costs: £1,285,050

Operating costs: £585,900

Staff costs: £198,050

Fixed costs: £72,850

Variable costs: £315,000

Summary of costs

* The figures in this appendix are based on the experience of the Guy’s and St Thomas’ Clinical PET Centre in 2001.

Page 36: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

reports and provide general administrative support. In addition, two 0.5 WTE clinical appoint-

ments would provide scan reporting and medical support. This assumes that basic FDG imaging

is being performed.

30

Appendix 1

Table 1 Capital costs for imaging with a distant supply of tracer. VAT is not included.

Item Quantity Costs (£)

PET scanner 1 1,200,000

Capintec 1 5,000

Protected bench 1 16,000

Lead safe 1 5,000

Protected injection devices 3 600

Hand/area radiation monitors 2 3,000

Emergency trolley 1 6,000

Pulse oximeter 1 2,000

Blood glucose monitor 1 500

Patient trolleys 2 1,850

Transportation pot 1 4,500

Workstations 2 10,000

Hard disks (36Gby) 2 1,000

Tape drives 2 1,000

Image printer 1 12,000

PCs (general use) 6 6,000

Text printer 1 600

Furniture – 10,000

Total 1,285,050

Table 2 Staff costs per annum for imaging with a distant supply of tracer. These figures assume athroughput of 1,000 patients each year, and include London weighting and on-costs.

Grade WTEs Total salary costs (£)

Radiographer (senior 1/MTO 3) 1 29,200

Radiographer (senior II/MTO 2) 2 50,000

Clinical scientist (physicist) 1 30,800

Consultant physician 1 (0.5 + 0.5) 65,700

Receptionist/secretary (grade 4) 1 19,850

Training/uniforms etc – 2,500

Total 198,050

Page 37: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

Fixed costs

Fixed costs are itemised in Table 3 and include the cost of a fully comprehensive maintenance

contract for the scanner and associated workstations. The cost of space allocation has not been

included but contract cleaning is listed. Germanium rod sources need to be replaced yearly and

are therefore included. Costs associated with the initial marketing of the service and educational

sessions for potential referrers have also been included.

Variable costs

Variable costs are identified at £315 per patient scan. This includes the delivery of tracer doses

at £300 per patient dose (assuming that a dose is defined as 350MBq) of FDG. VAT has not been

included. The cost of radiotracer supply will vary depending on the distance between the scanner

and the production facility. For the purposes of this paper it has been assumed that there is a

maximum time of one half-life between dispatch from the production site to the first patient

administration. Doses for subsequent patients will need to be decay-corrected appropriately for

timed administrations. It is usually possible for 3–4 patient doses to be included in one delivery

but this will depend on activity available from each production run. Radiotracer and delivery

costs will inevitably increase with distance from the production facility. The market for

radiotracers is increasing rapidly and costs are likely to be subject to variations as commercial

suppliers enter the market. Basic consumable costs per patient scan have also been included.

31

Appendix 1

Table 3 Fixed costs per annum for imaging with a distant supply of tracer.

Item Costs (£)

Scanner maintenance 50,000

Computer maintenance 750

Housekeeping contract 4,500

Marketing/education 5,000

Rod sources 6,000

Building maintenance 6,600

Total 72,850

Table 4 Variable costs per annum for imaging with a distant supply of tracer. These figures assume athroughput of 1,000 patients per year.

Item Costs (£)

350MBq FDG and transport 300,000

Scanning supplies (needles, syringes, linen etc) 10,000

Data storage 1,000

Hard copy and stationery 4,000

Total 315,000

Page 38: Positron emission tomography - NCRI PET · Positron emission tomography (PET) has been in use for over 20 years as a research tool, and over the last decade in a clinical role. The

APPENDIX 2Imaging with full production of tracer : theminimum establishment*

Capital costsScanning costs are as per the remote site, but with the addition of a syringe pump and ECG

monitoring to enable stress heart studies to be performed. If quantitative research studies are

to be performed a gamma counter, fluid analyser and associated equipment for handling blood

sampling would be required.

Imaging

32

Capital costs: £2,761,750

Imaging facility: £1,292,050

Radiotracer production: £1,469,700

Operating costs: £670,850

Staff costs:

Scanning: £301,300

Radiotracer production: £140,700

Fixed costs:

Scanning: £72,850

Radiotracer production: £74,000

Variable costs:

Scanning: £18,000

Radiotracer production: £64,000

Summary of costs

Table 5 Total capital scanning costs for imaging and radiotracer production facility.

Item Quantity Costs (£)

Scanning room (as per Table 1) 1,285,050

Syringe pump 1 2,000

12 lead ECG machine 1 5,000

Total 1,292,050

* The figures in this appendix are based on the experience of the Guy’s and St Thomas’ Clinical PET Centre in 2001.

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Equipment to enable production of the main clinical tracers has been itemised. It is assumed

that FDG will be produced for use internally and for distribution. Quality control equipment

has therefore been included to enable the centre to perform rigorous analysis of FDG in particular

in order to comply with present Medicines Control Agency (MCA) regulations and the European

Pharmacopea entry.

Commercial chemistry modules for the production of FDG and C-11 Methionine have been

included. It should be noted that the commercial market for these units is developing rapidly

and pricing is competitive. As with the previous model, building costs or renovation of existing

space have not been included.

Operating costsThis model assumes that the scanning and radiotracer production facility operates as an

integrated unit within areas of shared expertise and resources. Internal cross-charging for FDG

tracer doses has not therefore been itemised. The costs associated with FDG production are

included in the operating costs of the cyclotron and radiotracer production.

It has been assumed that this facility would scan in the region of 1,200+ patients per year, giving

an average throughput of five patients per day. Scanning is said to be five days per week for 48 weeks

of the year, allowance being made for maintenance, breakdown and bank holidays. This level of

throughput has been based on the experience of one centre performing oncological, cardiological

and neurological scans as well as some research studies. This may be considered to be a fairly

conservative estimate which will be affected by variations in patient mix and protocol design. Faster

scanners coming on to the market should also improve the throughput of patients.

Staff costs

This model would require a staffing complement similar to the previous model. However with an

on-site cyclotron and production facility it is likely that more complex clinical imaging and some

research would be undertaken during a longer working day. The staff costs for the scanning facility

therefore reflect this and anticipate some shift work to accommodate the longer scanning times

and increased patient throughput. There is a requirement for two WTE physics and computing

personnel to provide support for data processing and storage, scanner quality control, trouble-

shooting and the development of image processing protocols for clinical and basic research studies.

If complex quantitative research protocols are envisaged then additional physics and computing

staff will be required. Secretarial/reception support of one WTE is listed. An additional 0.5–1 WTE

SpR will be required for medical support, training and scan reporting. The complexity of the total

operation requires a person in the position of manager/administrator who is able to co-ordinate

the activities of the centre as a whole. This would include strategic planning, the setting and

monitoring of budgets, marketing and arranging contracts for FDG supply and distribution, and

day-to-day operational management. If the centre is under the management of nuclear medicine

or radiology, some of these activities may be undertaken by personnel or departments already in

existence. However it is likely that, having invested in a radiochemistry production facility, there

will be a significant commercial component to the operation which will require careful planning

and on-going management if the full potential is to be realised.

Imaging

Radiotracerproduction

33

Appendix 2

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34

Appendix 2

Table 6 Capital costs for full production of radiotracer within an imaging and full production oftracer facility.

Item Quantity Costs (£)

Cyclotron and laboratory infrastructure

Cyclotron 1 1,000,000

Isolator cabinet 1 40,000

Dispenser 1 15,000

Dose meters (Mini-Inst) 2 2,000

Surface/hand monitors 2 4,500

Area monitors (Lab Impex) 6 9,000

Personal radiation monitors 6 1,200

Fume cupboards 2 6,000

Total 1,077,700

FDG production

FDG box 1 50,000

Mini hot cell 1 30,000

Lead castles – 15,000

Total 95,000

C-11 production

C-11 chemistry module 1 60,000

Hot cell 1 50,000

Gradient pump 1 13,000

UV detector 1 6,000

Rad detector 1 8,000

Total 137,000

QC equipment

Dionex PED detector 1 20,000

Isocractic pump 1 5,000

Rad detector 1 6,000

PC, software and printer 1 7,000

TLC scanner 1 25,000

Suppressor 1 2,000

Injector 1 750

Gradient pump 1 12,000

UV detector 1 6,000

Rad detector 1 8,000

Injector 1 750

PC, software and printer 1 7,500

Gas chromotograph 1 16,000

Chart recorders 2 3,000

Oven 1 1,500

Total 120,500continued

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35

Appendix 2

Table 6 continued.

General laboratory equipment

Refrigerator 1 400

Freezer 1 200

Assorted glassware 400

Assorted tweezers and tongs 500

Lead safe 1 3,000

Lead pots 20 1,000

Balances 2 5,000

Pipettes 3 400

Solvent cupboards 2 400

Internal transport trolley 1 2,000

Capintecs 2 10,000

Crimping tool 1 200

Decrimping tool 1 200

Rad detector (GM tube) 1 1,000

Lead syringe shields 8 1,000

Osmolality kit 1 2,000

Shielded delivery boxes 2 5,000

Ultrasonic bath 1 400

LAL test kit 1 400

Laboratory/office furniture 6,000

Total 39,500

Total capital costs 1,469,700

Table 7 Staff costs per annum for imaging within an imaging and full production of tracer facility. Thesefigures assume a throughput of 1,200+ patients per year, and include London weighting and on-costs.

Grade WTE’s Total salary costs (£)

Radiographer (supt III/MTO 4) 1 31,800

Radiographer (senior I/MTO 3) 1 29,200

Radiographer (senior II/MTO 2) 1.5 37,500

Clinical scientist (physicist) 1 30,800

Systems administrator 1 26,500

Consultant physician 1 (0.5 + 0.5) 65,700

SpR 0.5 17,950

Receptionist/secretary (grade 4) 1 19,850

Manager/administrator 1 38,000

Training, uniforms etc 4,000

Total 301,300

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To maintain a reliable daily production of 18F-fluoride based radiotracers for internal and

external distribution, in addition to a variety of shorter half-life tracers, a minimum complement

of two radiochemists and a laboratory technician working a flexible rota would be required. A

minimum of two WTE cyclotron technicians with the experience and capability to trouble-shoot

and provide first line maintenance is also necessary. It may be possible to cross-train cyclotron

and chemistry staff to perform routine functions in the laboratory to increase flexibility, but

this would not reduce the need for experienced and competent technicians and chemists.

Staffing for the cyclotron and radiotracer production facility has assumed that the following

routine clinical radiotracers are available: 18FDG, N13H3, C11 Methionine and H2O15.

State-of-the-art FDG chemistry processing units are providing increasing yields and reduced

turnaround times. This enables one production site to support a number of imaging units.

Capital investment in additional imaging equipment will be required as patient numbers increase;

however, placing these facilities strategically with respect to the production facility remains the

most cost effective means of providing a comprehensive service for PET scanning. Extra staff

would be required for extra production runs, to operate additional cameras and to perform

more complex research studies, but optimum equipment usage can be achieved by flexible

staffing and extended hours of operation. The configuration of the imaging sites in relation to

the production facility is crucial to the optimum use of this expensive resource.

Fixed costs

The scanning component would not differ significantly from the remote site (£72,850 – see table 3).

Fixed costs for the production facility include contract maintenance for the cyclotron and items

of laboratory equipment. It should however be noted that maintenance expertise from supplying

companies may not be well developed in the UK. Trouble-shooting expertise and first-line

maintenance provided on-site is invaluable and could be deemed essential if a reliable service

of daily radiotracer production is to be supported (see section of staff training). General plant

maintenance costs, power usage and housekeeping are also included.

Radiotracerproduction

Imaging

Radiotracerproduction

36

Appendix 2

Table 8 Staff costs for the cyclotron and radiochemistry within an imaging and full production of tracerunit. These figures assume a throughput of 1,200 patients each year, and include London weighting andon-costs.

Grade WTEs Total salary costs (£)

Senior radiochemist RA1A/MTO4 1 33,250

Radiochemist RA1A/MTO3 1 28,600

Chemistry technician MTO2 1 18,250

Cyclotron technologists 2 58,600

Training, uniforms etc – 2,000

Total 140,700

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Variable costs

Assuming that the cyclotron production facility supplies radiotracers to the scanning unit, costs

associated with medical/injection supplies, data storage, stationery and hard copy production

are included (assuming a throughput of 1,200 patients per annum).

Laboratory supplies and cyclotron gases are included in this sum in addition to the production

chemicals and target materials. It should be noted that the target material for 18F-, O18 water

is an expensive commodity which is presently in short supply worldwide.

When pricing scans and radiotracer doses the cost of replacement equipment must be considered.

A PET scanner can be used for 8–10 yrs whilst computing equipment will generally need to be

replaced in 2–3 yrs.

The cyclotron will be operational over a longer period, around 20 years, but provision will need

to be made for replacement of some major parts depending on how the maintenance programme

is structured.

Replace-ment

programme

Radiotracerproduction

Imaging

37

Appendix 2

Table 9 Fixed radiotracer production costs.

Item Cost (£)

Cyclotron maintenance 50,000

Laboratory equipment maintenance 5,000

Power/building maintenance 15,000

Housekeeping contract 4,000

Total 74,000

Table 10 Variable scanning costs.

Item Cost (£)

Scanning supplies (needles, syringes, linen etc) 12,000

Data storage 1,200

Hard copy and stationery 4,800

Total 18,000

Table 11 Radiotracer production variable costs.

Item Cost (£)

Laboratory supplies 25,000

Chemicals/target materials 30,000

Gases 9,000

Total 64,000

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APPENDIX 3Training issues

There are training issues associated with all the disciplines involved in PET scanning. There are

few trained PET radiochemists in the world let alone the UK. Consequently there is a need to

establish a comprehensive training programme which could be organised either through MSc

courses or vocational training by an approved university course. This needs to be established as

a matter of urgency. Similarly there are few trained cyclotron engineers/technicians, and whilst

other disciplines (ie radiotherapy workshop technologists) do have some of the skills, there is a

need for experience in trouble shooting and first-line maintenance skills. Formal training and

on the job experience is required for these key members of the production team. The current

difficulties in recruiting nuclear medicine technologists and radiographers for general

departments are exacerbated when attempting to recruit for PET centres. Experienced, trained

staff are not readily available in the UK and training needs to be given on site. BSc courses now

include some PET lectures and an annual course is now offered by Guy’s & St Thomas’ PET

Centre but on the job training is required. Arranging rotations or split posts with other cross-

sectional imaging departments such as CT or MRI may make these positions more attractive to

radiographers who have not trained in nuclear medicine. There are few trained PET clinicians.

Training for clinicians is being addressed by including PET as part of the CCST training in

nuclear medicine but post-CCST experience is also required. There are few centres in the UK

where this experience can be gained and consequently it has been necessary for clinicians to gain

on the job experience or to spend short periods in overseas centres. This will be a significant

issue in the clinical staffing of PET centres.

The delivery and maintenance of the service needs to be consistent with the Ionising Radiation

(Medical Exposure) Regulations 20004 and the relevant aspects of IRR 199921 and ARSAC. It

also needs to comply with necessary standards of delivery of a high quality service as well as

issues related to clinical governance.

38

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