ACRIN 6671/GOG 0233

Consent for Research Study

A Study for Women with Advanced Cervical Cancer:

Learning whether an MRI scan with an investigative contrast agent (called ferumoxtran-10) or a PET/CT scan

can help doctors provide better treatmentThis research is a collaborative effort between two National Cancer Institute (NCI) cooperative groups:

Gynecologic Oncology Group (GOG) and the American College of Radiology Imaging Network (ACRIN).

ACRIN 6671/GOG 0233

Purpose of StudyThe main goals of this research study are:

1. To determine if a PET/CT scan, an MRI scan using an investigative contrast agent, or both can identify cancer that may have spread to your lymph nodes.

2. To determine if the investigative contrast agent (the scientific name is ferumoxtran-10) helps MRI scans locate cancer in lymph nodes.

ACRIN 6671/GOG 0233

About the Investigative Agent Ferumoxtran-10

The investigative contrast agent (ferumoxtron-10) is a substance given through an injection a day before the MRI exam.

Other studies have shown that it may help to find cancer in lymph nodes, which helps determine the best treatment for patients.

Ferumoxtran-10 was developed so that cancerous lymph nodes could be seen more clearly on MRI

scans.

ACRIN 6671/GOG 0233

Participation Requirements You will be in this study during the entire time

you are receiving treatment. You will be asked to visit the office for

follow-up exams for five (5) years following treatment.

Your participation is voluntary and you may stop at any time.

ACRIN 6671/GOG 0233

Participation Requirements cont.Your doctor may decide to stop your

participation in this study if: It could benefit your health Funding for the study has stopped Your health worsens New information becomes available

ACRIN 6671/GOG 0233

Study Procedures PET/CT scans performed during the study:

• Scan 1 – prior to a biopsy and before you begin your chemo radiation treatment

• Scan 2 – you may have a second PET/CT scan if:

– It is the standard treatment at your center

– a finding was visible on the PET/CT that could not be biopsied

MRI (with the investigative contrast agent):– One will be performed 24-36 hours after the injection of

the special contrast agent (ferumoxtran-10)

ACRIN 6671/GOG 0233

Study Procedures cont.Surgery (lymph node dissection):

Will be performed prior to beginning your chemo radiation treatment

Certain lymph nodes will be removed and examined to see if your cancer has spread

• You will remain in the hospital until you have recovered from your surgery

• Recovery from surgery usually takes approximately 1-3 days

ACRIN 6671/GOG 0233

About the PET/CT 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 uses a small amount of a radioactive drug, or tracer, to show

differences between healthy and diseased tissue. The most commonly used tracer – and the one used for this study – is called FDG (fluorodeoxyglucose), so the test is sometimes called an FDG-PET scan.

CT is a special type of x-ray machine that produces detailed images of the body part of interest.

Many PET scanners include CT scanners, thus giving us PET/CT scanners. This combination provides the most complete information about both anatomy (CT) and cell function (PET).

ACRIN 6671/GOG 0233

About MRI Scans Magnetic Resonance Imaging (MRI) uses a powerful magnet to

create radio frequency signals that a computer uses to make detailed pictures of areas inside the body without the use of radiation.

For the MRI scan, you will receive an injection of the MRI investigative contrast agent called ferumoxtran-10.

Some participants (40 total) may choose to have another MRI scan before having the MRI scan with the investigative contrast agent.

ACRIN 6671/GOG 0233

About MRI Scans cont.

The contrast drug helps to make any abnormal lymph nodes easier to see on the MRI scan.

You will have the injection between 24 and 36 hours before the MRI scan. In rare cases, this may be done up to 48 hours. The investigational agent that is being studied is called ferumoxtran-10.

ACRIN 6671/GOG 0233

Standard Medical Procedures Physical examination Medical history, including pregnancy test Tumor measurement Blood tests Chest x-ray Electrocardiogram (ECG)

– records the electrical activity of the heart over time

ACRIN 6671/GOG 0233

Treatment Options If you chose not to participate, the care you

receive will not be affected. Your doctor can talk to you about different

treatment options for your cervical cancer other than this research study.

ACRIN 6671/GOG 0233

Risks Associated with Study Participation

If you chose to participate in this study, you are at risk of 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/CT scans• Contrast agent (ferumoxtran-10)• MRI scans• Surgery (lymph node dissection)

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

ACRIN 6671/GOG 0233

Benefits of ParticipationWhile this study may or may not be of direct medical benefit to you, your participation could: Help doctors determine whether PET/CT and MRI scans

(using ferumoxtran-10) can identify cancer that has spread to lymph nodes

Help doctors determine the best treatment for patients with cervical cancer

Allow doctors to possibly change treatments if a better option is available

ACRIN 6671/GOG 0233

Patient Confidentiality Every effort will be made to keep your personal information

confidential. Confidential copies of your records will be stored in the

following locations while you are on the study:• The participating institution• American College of Radiology (ACRIN)• Gynecologic Oncology Group (GOG)

Organizations such as ACRIN, GOG, Food and Drug Administration (FDA), AMAG Pharmaceuticals (manufacturer of ferumoxtran-10), National Cancer Institute (NCI) and the Institutional Review Board (IRB) may inspect or copy your records for quality assurance and data analysis.

ACRIN 6671/GOG 0233

Cost of Participation There is no additional cost to the patient for

participation in this study. Please speak with your doctor or research

associate about specific details regarding reimbursement, any added costs or insurance problems.

ACRIN 6671/GOG 0233

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 who

you should contact at their Institutional Review Board (IRB)