1. ACRIN 6671/GOG 0233 Consent for Research Study A study for Women with Advanced Cervical Cancer: Learning whether a PET/CT scan using an imaging agent called FDG (Fluorodeoxyglucose) can help doctors provide better treatment This 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)

2. ACRIN 6671/GOG 0233 Purpose of Study  The main goal of this research study is: To determine if a PET-CT scan using the imaging agent (Fluorodeoxyglucose) FDG can find cancer that may have spread to your lymph nodes.

3. ACRIN 6671/GOG 0233 Participation Requirements  You will be in this study during the entire time you are receiving the 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.

4. 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

5. 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: o It is the standard treatment at your center o A finding was visible on the PET/CT that could not be biopsied

6. ACRIN 6671/GOG 0233 Study Procedures cont.  Surgery (lymph nodes 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 o You will remain in the hospital until you have recovered from your surgery o Recovery from surgery usually takes approximately 1-3 days

7. 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 scan uses a small amount of a radioactive imaging agent to show differences between healthy and diseased tissue. The most commonly used agent – 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).

8. 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

9. 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.

10. 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 Imaging Agent Surgery (lymph node dissection)  If you are pregnant or plan to become pregnant, you should not participate in this study due to reproductive risks.

11. ACRIN 6671/GOG 0233 Benefits of Participation  While this study may or may not be of direct medical benefit to you, your participation could: Help doctors determine whether PET/CT using FDG 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 treatment if a better option is available.

12. ACRIN 6671/GOG 0233 Patient Confidentiality  Every effort will be made to keep your personal information confidential.  Organizations such as American College of Radiology Imaging Network (ACRIN), Gynecology Oncology Group (GOG), Food and Drug Administration (FDA), National Cancer Institute (NCI) and the Institutional Review Board (IRB) may inspect or copy your records for quality assurance and data analysis.

13. 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.

14. 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).