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.

Research Protocol ACRIN 6678 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.

Research Protocol ACRIN 6678 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.

Research Protocol ACRIN 6678 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.

Research Protocol ACRIN 6678 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.

Research Protocol ACRIN 6678 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.

Research Protocol ACRIN 6678 Study Procedures Study 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

Research Protocol ACRIN 6678 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

Research Protocol ACRIN 6678 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.

Research Protocol ACRIN 6678 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.

Research Protocol ACRIN 6678 Standard Medical Procedures The 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 Protocol ACRIN 6678 Research Trial Procedures As 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.

Research Protocol ACRIN 6678 Benefits of Participation While 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 2 nd 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.

Research Protocol ACRIN 6678 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

Research Protocol ACRIN 6678 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.

Research Protocol ACRIN 6678 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)

Research Protocol ACRIN 6678 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 6678 Cost of Participation Please speak with your doctor or research associate about specific details regarding possible added costs or insurance related concerns.

Research Protocol ACRIN 6678 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 CANCER ( ).