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Research Protocol ACRIN 6678 Learning About PET/CT Scans:

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  • 1. 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.
  • 2. 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. Approximately 228 people will participate.
  • 3. 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.
  • 4. 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.
  • 5. Research Protocol ACRIN 6678 Participation Requirements  Participants will be active in the study approximately 6 months (24 weeks) while undergoing chemotherapy.  Following treatment, study participants will need to schedule follow-up doctor visits as their doctor recommends.  Participation is voluntary and may be stopped at any time.
  • 6. 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.
  • 7. Research Protocol ACRIN 6678 Study Procedures Study participants will be assigned into one of two groups as randomly chosen by a computer:  Group A or Group B. Participants in each group will undergo:  3 PET/CT Scans.
  • 8. 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 • Scan 3 – after the first cycle of chemotherapy  Group B participants will undergo 3 PET/CT scans. • Scan 1 – before cancer treatment • Scan 2 – after the first cycle of chemotherapy • Scan 3 – after the second cycle of chemotherapy
  • 9. Research Protocol ACRIN 6678 Study Procedures cont. About the CT Scans:  All study 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.
  • 10. 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).
  • 11. Research Protocol ACRIN 6678 Treatment Options As part of this study, additional PET/CT scans will be performed. 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.
  • 12. 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 2nd treatment)  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.
  • 13. 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
  • 14. 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.
  • 15. 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)
  • 16. 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).
  • 17. 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.
  • 18. 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 1-800-4-CANCER (1-800-422-6237).