Transcript study - acrin

Consent for Research Study
A study using 18F-Fluoride for prostate cancer
patients currently enrolled in Dr. Febbo’s
“Genomic Guided Therapy” study
A research study coordinated by the
American College of Radiology Imaging Network (ACRIN)
Purpose of the Study
• The study’s main goal is to learn if the images
provided by a PET scan using 18F-fluoride can help
doctors determine any changes the dasatinib is having
on bone metabolism and blood flow.
• The ACRIN trial will enroll 24 participants who are
receiving dasatinib in Dr. Febbo’s study
Research Protocol ACRIN 6687
Participation Requirements
• If you agree to take part in this study, you will have
the following procedures:
• Two (2) PET scans with 18F-fluoride given through an
IV.
– You will have one (1) 18F-fluoride PET scan within 7 days
before starting treatment with dasatinib for your prostate
cancer.
– You will have one (1) 18F-fluoride PET scan approximately
12 weeks after you have your first dasatinib treatment
Research Protocol ACRIN 6687
Participation Requirements
• You will be involved with this study’s imaging
procedures for about 16 to 18 weeks.
• Each PET imaging visit will require about two (2) to
three (3) hours of your time.
• Study doctors will review your medical records for up
to 5 years, to compare the results of the PET scan with
the course of your cancer.
Research Protocol ACRIN 6687
18F-fluoride
PET
(Positron Emission Tomography)
• PET is a nuclear medicine imaging scan that produces
3-D images (pictures) that provide information about
cell function and show the difference between healthy
tissue and diseased tissue.
•
18F-fluoride
is a new tracer used during a PET scan
that is being evaluated to help doctors learn how the
drug dasatinib changes your bone cancer and your
healthy bone as well
Research Protocol ACRIN 6687
Participation Requirements
• This study may be stopped at any time by your
study doctor, ACRIN, FDA, and/or NCI
without your consent should:
– Your health or safety be at risk;
– The study drug will no longer be available;
– An administrative decision made by the study
doctor, ACRIN, FDA, and/or NCI.
Research Protocol ACRIN 6687
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 prostate cancer in the
future
• Help doctors determine the best way to evaluate people with
prostate cancer that has spread to the bone
Research Protocol ACRIN 6687
Support During Participation
The doctors and nurses will provide a
supportive environment for participants and
will:
• assist in scheduling scans,
• answer procedure questions, and
• make your involvement as comfortable as
possible.
Risks Associated With Participation
• If you choose to participate in this study, you may be
at risk for side effects.
• Side effects from your scan are rare; however, any
side effects you should experience are likely to go
away shortly after the imaging scan is stopped and IV
catheter is removed.
• Other drugs may be given to make side effects less
serious and uncomfortable.
Research Protocol ACRIN 6687
Patient Confidentiality
• Every effort will be made to keep your personal
information confidential.
• Confidential copies of your study records will be kept
at the hospital or medical center where you receive
your scan.
• Study data and images sent to the American College of
Radiology Imaging Network (ACRIN) in Philadelphia,
PA will first have the study participant’s information
removed.
Research Protocol ACRIN 6687
Patient Confidentiality cont.
Organizations such as the following may inspect or
copy your records for quality assurance:
•
•
•
•
•
•
Food and Drug Administration (FDA)
National Cancer Institute (NCI)
Institutional Review Board (IRB)
ACRIN Statistical Center
ACRIN
Bristol Myers Squib
Research Protocol ACRIN 6687
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 6687
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 6687