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Research Protocol ACRIN 6684

Consent for Research Study A study for patients newly diagnosed with advanced glioblastoma (brain cancer): Learning whether a PET scan with F-fluoromisonidazole (FMISO) can help doctors tell if a tumor is getting enough oxygen for treatment to be effective.

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Research Protocol ACRIN 6684

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  1. Consent for Research StudyA study for patients newly diagnosed with advanced glioblastoma (brain cancer): Learning whether a PET scan with F-fluoromisonidazole (FMISO) can help doctors tell if a tumor is getting enough oxygen for treatment to be effective A research study coordinated by the American College of Radiology Imaging Network (ACRIN) Research Protocol ACRIN 6684

  2. Purpose of the Study The main goal of this research is: To add to doctors’ knowledge of how a tumor’s lack of oxygen (hypoxia) and cancer treatments are related in order to best manage treatment for people with brain cancer About 50 people from 4 to 10 institutions will take part in this study. Research Protocol ACRIN 6684

  3. Participation Requirements You will be involved with the study’s imaging procedures for about 12 weeks after you are enrolled. Following completion of the PET scanningyou will resume follow-up scanning according to your doctor’s recommendations. Your treating doctor will provide information on your health and disease status to study doctors for up to 3 years after study completes enrollment Your participation is voluntary; you may stop at any time. Research Protocol ACRIN 6684

  4. Participation Requirements cont. The study may be stopped at any time by your study doctor or administrators if: Your health or safety is at risk The imaging agentis no longer available New information becomes available that might change your mind about participating An administrative decision is made by the study doctor or affiliated agencies Research Protocol ACRIN 6684

  5. Study Procedures PET scans with FMISO performed during the study: Within 2 weeks prior to starting treatment for your brain cancer Within 1 week prior to the start of treatment (only 15 participants will undergo this additional PET scan) About 3-4 weeks after starting your treatment 3-5 weeks after you have completed treatment MRI scans performed: You will undergo 1 more MRI scan with gadolinium contrast during your treatment than if you choose not to participate in the study Research Protocol ACRIN 6684

  6. Study Procedures cont. Blood samples taken during the study: Small amounts of blood will be taken during each of your scanning visits. You may undergo the FMISO PET scans and MRI scans on the same day or on separate days, according to your doctor’s recommendations and your preference. Research Protocol ACRIN 6684

  7. Imaging Timeline Visit 2 A: For first 15 patients PET Scan 1 to 7 days after first PET scan and before tx begins Visit 4: PET and MRI Scans 4 weeks (28 days) after tx Visit 1: Identify eligible patient and consent them to trial Visit 2: PET and MRI Scans 1 to 14 days before tx begins Visit 3: PET and MRI Scans 3 wks (21 days) after the start of tx

  8. About PET Scans with FMISO PET is a nuclear medicine imaging technique that produces a 3-D image of cell function in the body. A PET scan is performed after a small amount of a radioactive drug (called a “radioligand”) is injected into the body to help identify differences between healthy and diseased tissue. FMISO, the new radioligand used in this study, has been helpful in evaluating how well a tumor is getting oxygen, which may affect how well it responds to radiation and chemotherapy. Research Protocol ACRIN 6684

  9. About New MRI Image Techniques An MRI uses powerful magnets and radio waves linked to a computer to create clear and detailed cross-sectional images of the body. A liquid-like dye, called a contrast agent, is used during an MRI to help imaging machines create pictures of the body’s organs and bones. Gadolinium, a standard contrast agent used during MRI scans,will help doctors view your brain tumor. The MRI will measure characteristics of your tumor that seem related to whether it receives enough oxygen, including changes in blood flow, blood volume, and blood vessel size. Research Protocol ACRIN 6684

  10. Blood Sample Procedures Blood samples will be taken from an IV catheter each time you undergo a PET This catheter will be separate from the one used to inject the FMISO or the gadolinium contrast. The amount of FMISO in the blood samples helps doctors determine how much FMISO is being absorbed by the tumor, which tells them how much oxygen the tumor is getting. Research Protocol ACRIN 6684

  11. Study Procedure This study will also use a second method of measuring FMISO absorption that compares the amount of FMISO shown on the tumor PET scan with the amount shown in the normal area of the brain. If this more convenient method is found to accurately measure the FMISO absorption, doctors may be able to use it to replace the blood sampling method. Research Protocol ACRIN 6684

  12. Standard Medical Procedures The following are part of regular cancer care for glioblastoma: Chemotherapy (temozolomide) Radiation therapy One MRI scan with gadolinium contrast prior to chemoradiation and after completion of chemoradiation Physical examination Short mental health examinations Neurologic examination Routine blood laboratory studies Pregnancy test (if applicable) Research Protocol ACRIN 6684

  13. Treatment Options If you choose not to participate, the care you receive will not be affected. You could undergo PET and MRI scans without participating in this study; please discuss this and other options with your treating doctor Research Protocol ACRIN 6684

  14. Benefits of Participation Although this study is not designed to be of direct medical benefit to you, your participation could: Give you the satisfaction of being part of an effort with the potential to benefit other patients with brain cancer in the future Help doctors determine the best treatment approaches for people with certain types of brain cancer Help treatments work better in brain cancers that are difficult to treat The study team will provide a supportive environment for participants, assist in scheduling scans, answer procedure questions, and make their involvement as comfortable as possible. Research Protocol ACRIN 6684

  15. Risks Associated With Participation If you choose to participate in this study, you may be at risk for side effects. Your doctor or research associate will discuss these with you in more detail. Many side effects go away shortly after the imaging scan is stopped and IV catheters are removed. Other drugs may be given to make side effects less serious and uncomfortable. If you are pregnant, are breastfeeding, or plan to become pregnant or father a child, you should not participate in this study due to reproductive risks. Research Protocol ACRIN 6684

  16. Patient Confidentiality Every effort will be made to keep your personal information confidential. Confidential copies of your records during your participation will be kept at the following locations: The participating hospital or medical center American College of Radiology Imaging Network (ACRIN) headquarters in Philadelphia, PA Research Protocol ACRIN 6684

  17. 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 6684

  18. Cost of Participation Taking part in this study will not lead to added costs to you or your insurance company. Please speak with your doctor or research associate about specific details regarding reimbursement, any added costs, or insurance problems. Research Protocol ACRIN 6684

  19. 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 6684

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