Download Consent for Research Study A study for patients newly diagnosed

Consent for Research Study
A study for patients newly diagnosed with
head and neck cancer:
Learning whether an FDG-PET/CT scan
can help doctors provide better treatment
for head and neck cancer
A research study coordinated by the American
College of Radiology Imaging Network (ACRIN)
Research Protocol ACRIN 6685
Purpose of the Study
 The main purpose of this study is:
To help doctors see if FDG-PET/CT can more
accurately determine the stage of head and neck
cancer than physical examination, MRI or CT scans,
and surgery alone.
 Approximately 292 people from across the
country will take part in the study.
Research Protocol ACRIN 6685
Participation Requirements
• You will be actively involved in the study for
approximately 2 years.
• Following your FDG-PET/CT scan and neck
surgery, you will continue follow-up according to
your treating doctor’s recommendations.
• You will complete a survey about your quality of
life before the FDG-PET/CT scan and at 30
days, 1 year and 2 years after your surgery.
Research Protocol ACRIN 6685
Participation Requirements cont.
 The study may be stopped at any time by your
study doctor or administrators if:
• Your health or safety may be at risk
• You have not been following study instruction
• New information becomes available that might
change your mind about participating in the trial
• An administrative decision is made by the study
doctor or affiliated agencies
Research Protocol ACRIN 6685
Study Procedures
 Within 14 days of your surgery, you will undergo
a PET/CT scan using the drug FDG. FDG is also
called a “radiotracer”, or simply a “tracer”.
 Prior to the scan, an IV will be placed in a vein in
your arm to:
• Check your glucose levels
• Inject the FDG radiotracer
• Take a blood sample (this is optional).
Research Protocol ACRIN 6685
Study Procedures cont.
 If you agree to an optional blood collection for
research purposes, the following procedure
will be performed:
• One tube of blood will be taken from the IV placed
in a vein in your arm to inject the FDG.
• All your personal information will be removed from
the sample before it is shared and stored.
Research Protocol ACRIN 6685
Study Procedures cont.
 Your treating doctor will review the FDG-PET/CT
scan results before performing standard surgery
to remove lymph nodes from your neck.
• The surgery is not part of the study
 Your doctor may change his plans for surgery
based upon the FDG-PET/CT scan.
Research Protocol ACRIN 6685
About FDG-PET/CT Scans
 A PET scanner produces a 3-D image of cell
function in the body.
 A CT scanner is an x-ray machine sending
beams from multiple angles that produces a 2-D
picture of the area being examined.
 PET/CT fuses the results of both types of scans to
provide more complete information about a
patient’s cancer.
Research Protocol ACRIN 6685
About FDG-PET/CT Scans cont.
 A small amount of the radioactive drug (also
called a tracer) fluorodeoxyglucose (FDG) is
injected before the PET scan in this study.
• The PET/CT can pick up where this imaging agent
creates “hot spots” from within the cancer cells.
Research Protocol ACRIN 6685
Standard Medical Procedures
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Review of your medical history
Physical examination
Diagnostic MRI or CT scan
Surgery to remove lymph nodes from your neck
Pregnancy test (if applicable)
Research Protocol ACRIN 6685
Benefits of Participation
 Taking part in this study may or may not improve
your health
• The PET/CT scan results may allow your treating
doctor to change surgical and treatment strategies to
more effectively manage your head and neck cancer
 The knowledge gained from this study could
help doctors decide on the best treatment for
people with head and neck cancer in the future
Research Protocol ACRIN 6685
Participation Risks
 While on this study, you may be at risk for side
effects associated with the following procedures:
• Intravenous (IV) catheter placement
• FDG radioactive drug/tracer
• PET/CT scan
• Optional blood collection
 If you are pregnant or plan to become pregnant, you
should not participate in this study due to
reproductive risks
Research Protocol ACRIN 6685
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
 Study information and images will also be sent over
a secure Internet connection to the American
College of Radiology Imaging Network (ACRIN) and
stored in a secure computer.
Research Protocol ACRIN 6685
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 6685
Cost of Participation
 Please speak with your doctor, or study
coordinator, about the possibility of any added
costs or insurance problems as a result of
participation in this study.
 The cost of FDG-PET/CT scans for head and
neck cancer is:
• Covered by most insurance companies
• Reimbursed by the study if insurance coverage is not
obtained
Research Protocol ACRIN 6685
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 6685