Research Protocol ACRIN 6678 Learning About PET/CT Scans: Can PET/CT scans provide helpful information for the treatment of non-small cell lung cancer?

Research Protocol ACRIN 6678

Learning About PET/CT Scans:

Can PET/CT scans provide helpful information for the treatment of non-small cell lung cancer?

Patient consent overview for participation in a research study coordinated by the

American College of Radiology Imaging Network (ACRIN)

ACRIN is a member of the National Cancer Institute’s clinical trials cooperative group program and supports multi-center research related to medical imaging at over 100 participating institutions.


Purpose of the Study

The main goal of this research study is:

To determine if PET/CT scans can help doctors

decide if chemotherapy is working to control lung cancer.

A minimum of 228 people will participate.


What is a PET Scan? PET is a nuclear medicine imaging exam that produces a 3-D

image that provides information about cell function in the body.

PET scans use a small amount of a radioactive drug, or tracer, to show differences between healthy tissue and diseased tissue.

The most commonly used tracer – and the one used for this study – is called FDG (fluorodeoxyglucuse).

The test is sometimes called an FDG-PET scan.


What is a PET/CT Scan? Many PET scanners include a CT scanner, giving us

PET/CT.

The combination of PET/CT provides the most complete information about both anatomy (CT) and cell function (PET).

CT is a special type of X-ray machine that produces detailed images of the organ -- or anatomy -- of interest.


Participation Requirements Participation could be anywhere between 1 to 12 months, depending

upon a participant’s schedule.

Following treatment, study participants will need to schedule follow-up doctor visits as their doctor recommends. Medical care and treatment information may be collected for 12 months after study enrollment.

Participation is voluntary and may be stopped at any time.


Participation Requirements cont.Your doctor may also decide to stop your participation in this study if:

Your condition worsens You experience serious side effects from the

chemotherapy treatment The chemotherapy your doctor prescribes is not part of

the study.

New information becomes available The study is stopped early due to lack of funds or lack

of patient participation.


Study ProceduresStudy participants will pick with their doctor to join one of three study groups:

Group A, Group B, or Group C

Participants in group A will undergo: 3 PET/CT Scans

Participants in group B will undergo: 2 or 3 PET/CT scans

Participants in group C will undergo: 2 PET/CT scans


Study Procedures cont. Group A participants will undergo 3 PET/CT scans.

– Scans 1 and 2 – will be performed within 14 days before the cancer treatment begins

– Scan 3 – will be performed after the first cycle of chemotherapy

Group B participants will undergo 2 or 3 PET/CT scans.– Scan 1 – will be performed before cancer treatment– Scan 2 – will be performed after the first cycle of

chemotherapy– Scan 3 – (is optional) will be performed after the second

cycle of chemotherapy


Study Procedures cont.

Group C participants will undergo 2 PET/CT scans.– Scans 1 and 2 – will be performed

within 7 days of each other before any cancer treatment begins.


Study Procedures cont.

About the CT Scans:

Group A and B participants will undergo routine follow-up CT scans every six (6) weeks as part of their cancer treatment. The scan does not include contrast.

The scan results will be reviewed by your doctor for a maximum of eighteen (18) weeks.


Standard Medical ProceduresThe following are part of standard cancer care:

Chemotherapy A diagnostic CT scan to evaluate your cancer One PET/CT scan or PET scan Physical Examination Pregnancy Test (if applicable).


Research Trial ProceduresAs part of this study, additional PET/CT scans will be performed. In addition, you may consent to have CT scans called “volumentric" CT scans.

If you chose not to participate: PET/CT scans can still be done, however you

would need to speak to your doctor about this and other options

The care you receive will not be affected.


Benefits of ParticipationWhile this study may or may not be of direct medical benefit to you, your participation could:

Help doctors learn more about how to best treat your type of cancer and if the chemotherapy treatment is working (after the 2nd cycle of chemotherapy)

Allow doctors to see if PET/CT scans can help identify lung cancer that has spread

Ultimately help doctors determine the best treatment for lung cancer patients.


Risks Associated with Participation If you choose to participate in this study, there

are potential side effects.

Your doctor or research associate will discuss these with you in more detail.

The risk of side effect is associated with the following procedures:

• PET Scans • CT Scans


Risks Associated with Participation cont. These risks would be in addition to the side

effects you may experience from the chemotherapy treatment.

If you are pregnant or plan to become pregnant you should not participate in this study due to reproductive risks.


Patient Confidentiality All participant personal information will be kept

confidential. While you are in the study confidential copies of

your records will be stored in the following locations :– The participating hospital or medical center– American College of Radiology Imaging

Network (ACRIN)


Patient Confidentiality cont.Organizations such as the following may inspect or copy your records for quality assurance and data analysis:

ACRIN Statistical Center Food and Drug Administration (FDA) National Cancer Institute (NCI) Institutional Review Board (IRB).


Cost of Participation

Please speak with your doctor or research associate about specific details regarding possible added costs or insurance related concerns.


If you have questions… Regarding the research study:

• Contact the study doctor or research associate Regarding patients’ rights:

• Ask your study doctor or research associate for an Institutional Review Board (IRB) contact

Regarding general cancer research: • Call the NCI’s Cancer Information Service at

1-800-4-CANCER (1-800-422-6237).

Documents

Research Protocol ACRIN 6678 Learning About PET/CT Scans: Can PET/CT scans provide helpful information for the treatment of non-small cell lung cancer?