Transcript Informed consent flip chart

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 12 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 3
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)
• 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
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
Imaging Timeline
Visit 1: Identify
eligible patient and
consent them to trial
Visit 2 A: For first 15 patients
Visit 4: PET and MRI Scans
PET Scan
4 weeks (28 days) after tx
1 to 7 days after first PET scan and
before tx begins
Visit 2: PET and MRI Scans
Visit 3: PET and MRI Scans
1 to 14 days before tx begins
3 wks (21 days) after the
start of tx
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
About New MRI Image Techniques
 An MRI uses powerful magnets and radio waves linked
to a computer to create clear and detailed crosssectional 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
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 (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
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:
• 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
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
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
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
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