A research study coordinated by the American College of Radiology Imaging Network (ACRIN)

1. Consent for Research StudyA study for patients newly diagnosed with head and neck cancer:Learning whether an FDG-PET/CT scan can help doctors provide better treatment for head and neck cancer A research study coordinated by the American College of Radiology Imaging Network (ACRIN) Research Protocol ACRIN 6685

2. The main purpose of this study is: To help doctors see if FDG-PET/CT can more accurately determine the stage of head and neck cancer than physical examination, MRI or CT scans, and surgery alone. Approximately 292 people from across the country will take part in the study. Research Protocol ACRIN 6685 Purpose of the Study

3. Participation Requirements You will be actively involved in the study for approximately 2 years. Following your FDG-PET/CT scan and neck surgery, you will continue follow-up according to your treating doctor’s recommendations. You will complete a survey about your quality of life before the FDG-PET/CT scan and at 30 days, 1 year and 2 years after your surgery. Research Protocol ACRIN 6685

4. Participation Requirements cont. The study may be stopped at any time by your study doctor or administrators if: Your health or safety may be at risk You have not been following study instruction New information becomes available that might change your mind about participating in the trial An administrative decision is made by the study doctor or affiliated agencies Research Protocol ACRIN 6685

5. Study Procedures Within 14 days of your surgery, you will undergo a PET/CT scan using the drug FDG. FDG is also called a “radiotracer”, or simply a “tracer”. Prior to the scan, an IV will be placed in a vein in your arm to: Check your glucose levels Inject the FDG radiotracer Take a blood sample (this is optional). Research Protocol ACRIN 6685

6. Study Procedures cont. If you agree to an optional blood collection for research purposes, the following procedure will be performed: One tube of blood will be taken from the IV placed in a vein in your arm to inject the FDG. All your personal information will be removed from the sample before it is shared and stored. Research Protocol ACRIN 6685

7. Study Procedures cont. Your treating doctor will review the FDG-PET/CT scan results before performing standard surgery to remove lymph nodes from your neck. The surgery is not part of the study Your doctor may change his plans for surgery based upon the FDG-PET/CT scan. Research Protocol ACRIN 6685

8. About FDG-PET/CT Scans A PET scanner produces a 3-D image of cell function in the body. A CT scanner is an x-ray machine sending beams from multiple angles that produces a 2-D picture of the area being examined. PET/CT fuses the results of both types of scans to provide more complete information about a patient’s cancer. Research Protocol ACRIN 6685

9. About FDG-PET/CT Scans cont. A small amount of the radioactive drug (also called a tracer) fluorodeoxyglucose (FDG) is injected before the PET scan in this study. The PET/CT can pick up where this imaging agent creates “hot spots” from within the cancer cells. Research Protocol ACRIN 6685

10. Standard Medical Procedures Review of your medical history Physical examination Diagnostic MRI or CT scan Surgery to remove lymph nodes from your neck Pregnancy test (if applicable) Research Protocol ACRIN 6685

11. Benefits of Participation Taking part in this study may or may not improve your health The PET/CT scan results may allow your treating doctor to change surgical and treatment strategies to more effectively manage your head and neck cancer The knowledge gained from this study could help doctors decide on the best treatment for people with head and neck cancer in the future Research Protocol ACRIN 6685

12. Participation Risks While on this study, you may be at risk for side effects associated with the following procedures: Intravenous (IV) catheter placement FDG radioactive drug/tracer PET/CT scan Optional blood collection If you are pregnant or plan to become pregnant, you should not participate in this study due to reproductive risks Research Protocol ACRIN 6685

13. Patient Confidentiality Every effort will be made to keep your personal information confidential Confidential copies of your study records will be kept at the hospital or medical center Study information and images will also be sent over a secure Internet connection to the American College of Radiology Imaging Network (ACRIN) and stored in a secure computer. Research Protocol ACRIN 6685

14. 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) Research Protocol ACRIN 6685

15. Cost of Participation Please speak with your doctor, or study coordinator, about the possibility of any added costs or insurance problems as a result of participation in this study. The cost of FDG-PET/CT scans for head and neck cancer is: Covered by most insurance companies Reimbursed by the study if insurance coverage is not obtained Research Protocol ACRIN 6685

16. 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) Regarding general cancer research: Call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). Research Protocol ACRIN 6685