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ACRIN 6684 Flipchart

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					       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

      A research study coordinated by the American
      College of Radiology Imaging Network (ACRIN)
Research Protocol ACRIN 6684
          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
     Participation Requirements
 You will be involved with the study’s imaging procedures
  for about 2 weeks after you are enrolled.
 Following completion of the PET scanning you 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 5
  years after study completes enrollment
 Your participation is voluntary; you may stop at any time.



                       Research Protocol ACRIN 6684
 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 agent is 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
               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)
 MRI scan performed at the same time as the first PET
  scan within 2 weeks prior to starting treatment. This scan
  will be done whether you decide to participate in this
  study or not.
    Some new imaging techniques that are part of this study will be
     added to the standard MRI scan
                          Research Protocol ACRIN 6684
        Study Procedures cont.
 Blood samples taken during the study:
   • Small amounts of blood will be taken during each of
     your PET 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
                            Imaging Timeline


                                             Visit 2 A: For first 15 patients
Visit 1: Identify
eligible patient and                         PET Scan
consent them to trial
                                             1 to 7 days after first PET scan and
                                             before treatment begins



                Visit 2: PET and MRI Scans                                          Follow up: All MRI and CT
                                                                                    Scans will be sent to ACRIN
                1 to 14 days before treatment
                begins                                                              3 years for progression and
                                                                                    survivorship
  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 (sometimes referred to as an “agent”) is
  injected into the body to help identify differences
  between healthy and diseased tissue.
 FMISO, the new agent 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
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 used during an MRI scan to help the
  radiologist better see the tumor and other brain tissue..
 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
    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
              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
  Standard Medical Procedures
 The following are part of regular cancer care for
  glioblastoma:
   • Chemotherapy
   • 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
           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
        Benefits of Participation
 Although this study is not designed to be of direct
  medical benefit to you, your participation could:
   • Have 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
Risks Associated With Participation
  If you choose to participate in this study, you may be at
   risk for side effects.
  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.
  Let your doctor or research associate know if you have
   any questions about side affects.
                     Research Protocol ACRIN 6684
      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
  participating hospital or medical center
 Information that has all of your identification
  information removed will be stored at the American
  College of Radiology Imaging Network (ACRIN)
  headquarters in Philadelphia, PA

                  Research Protocol ACRIN 6684
      Patient Confidentiality cont.
• Organizations such as the following may inspect
  or copy your records for quality assurance and
  data analysis:
  •   ACRIN
  •   Food and Drug Administration (FDA)
  •   National Cancer Institute (NCI)
  •   Institutional Review Board (IRB)



                     Research Protocol ACRIN 6684
          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
        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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posted:5/24/2013
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