Transcript Consent Flip Chart -ENGLISH

Consent for Research Study
• A study for patients with a diagnosis of
liver cancer who are on the waiting list
for a liver transplant
• Comparison of advanced CT and MRI
scans for determining a patient’s liver
status
A research study coordinated by the American
College of Radiology Imaging Network (ACRIN)
Purpose of the Study
• This research study is being done to learn
whether images from a CT scan or from an MRI
scan provide the best information about liver
status
• The study doctors believe they can improve on
current methods of placing people with
advanced disease on the waitlist for liver
transplant
• 440 participants at approximately 25 to 30
centers will be involved in this study
Participation Requirements
Your direct participation will consist of:
• A screening visit
• Subsequent imaging sessions
• Both CT and MR scans (one is “standard of care” and the
other is a “study scan”) will be completed at 90-day
intervals until the time of liver transplantation
• If you undergo local ablative therapy after study
enrollment, additional CT and MRI scans may be
completed between 28 to 60 days after the therapy
• The extra scans following ablative therapy will not be
performed if the timing is within the 90-day routine scanning
session
Participation Requirements cont.
• The images from both CT and MRI scans will be compared
to the actual liver after it is removed during transplant
surgery
• Examining the liver with images from the scans will help the
study doctors understand which imaging method is better for
determining liver status
• Your participation is voluntary, you may stop at any time
• Your participation in this study may be stopped at any time
by the study doctor or the sponsor without your consent.
The reasons might include:
• The study doctor thinks it necessary for your health or safety;
• You have not followed study instructions;
• The sponsor has stopped the study;
• Administrative reasons require your withdrawal
About MRI Scans
• An MRI uses powerful magnets and radio waves
linked to a computer to create cross-sectional
images of the body, in this case of the liver
• A commonly used contrast agent called
“gadolinium” will be given in this study to better
see the liver tissues on the MRI images
• The contrast agent will be given via a small
intravenous (IV) line placed in a vein in your
arm
About CT Scans
• A CT uses special x-ray equipment to take
multiple images from different angles around the
body, in this case around the liver
• A commonly used iodine-based contrast agent
will be given to better see certain liver tissues on
the CT images
• The iodine-based contrast agent will be given
via a small intravenous (IV) line placed in a vein
in your arm
Study Procedures
• Enrollment Visit – this will take place within 30
days after being added to the waiting list for the
liver transplant
• The following procedures may be performed to
determine whether you meet the study entrance
requirements:
• A medical history will be taken
• Blood will be drawn to test your blood chemistry and
kidney function
• A pregnancy test will be conducted, if applicable
Study Procedures cont.
• Study Imaging – There will be following imaging sessions:
– The first study scan will be performed within 30 days of
trial enrollment:
• If the “standard of care” scan at the institution is MRI, the
“study scan” will be a CT
• If the standard of care scan at the institution is CT, the “study
scan” will be MRI
• If you had the standard of care scan more than 30 days prior
to study enrollment, you will have another standard of care
scan
– Every 90 days you will have both a standard of care scan
and a study scan
Study Procedures cont.
• If you receive ablative therapy, additional MRI and
CT imaging will take place after 28 to 60 days of
therapy, if applicable
• For each scan, the following procedures will be
performed:
• A pregnancy test will be conducted, if applicable
• Blood may be drawn to check your kidney health
• Get an intravenous (IV) catheter placed in your arm to
receive a contrast agent during both scans
Pathology on Removed Liver
• The results of both the CT and MRI scans will
directly be compared with the removed liver
• Images of the pathology work will be sent to
ACRIN for the study doctor to compare
• Samples of your removed liver may also be
requested by ACRIN for review
• All your personal information will be removed
prior to sending pathology images or samples to
ACRIN
Risks of Participation
While on the study, you may be at risk associated with:
• Intravenous Catheter Placement
• MRI
• CT
• Gadolinium and Iodine contrast used during scans
• Radiation exposure from CT scan
Be sure to ask any questions about the study’s risks
There may also be other side effects that neither your
doctor nor the research staff can predict
Benefits of Participation
• This is not a treatment study and you are not
expected to receive any direct medical benefits
from your participation
• The information learned from this study could
help doctors use better imaging techniques to
determine who is in greatest need for liver
transplant
• In the future, the information learned may benefit
other patients who have liver cancer and other
liver diseases
Patient Confidentiality
• Every effort will be made to keep your personal
information confidential
• Confidential copies of your records will be kept at
the participating hospital or medical center
• All information sent to ACRIN headquarters in
Philadelphia, PA will be coded so that study
participants can not be identified
Patient Confidentiality Cont.
• The following organizations may access
your records for quality assurance and
data analysis:
• ACRIN
• Food and Drug Administration (FDA)
• National Cancer Institute (NCI)
• Institutional Review Board (IRB)
Costs and Payment
•
•
•
Taking part in this study may lead to added
costs to you or your insurance company. The
standard-of-care expenses are usually covered
by most insurance companies but this is not
guaranteed.
ACRIN will pay for study-related imaging
scans. Please ask your doctor about any
expected costs or insurance problems.
You will not be paid for taking part in this study.
Participation Rights
• Taking part in this study is voluntary.
• You may choose not to take part or leave the
study at any time. Leaving the study will not
result in any penalty or loss of benefits.
• Your decision whether or not to participate in this
study will not interfere with your future care. You
will still get the care from the same institution.
If you have questions:
• Regarding the study:
 Contact the study doctor or research associate
• Regarding patient’s rights:
 Ask your study doctor or research associate who you
•
should contact at their Institutional Review Board
(IRB)
Regarding general cancer research:
 National Cancer Institute:
• www.cancer.gov; 1-800-4-CANCER
 American Cancer Society:
• www.cancer.org; 1-800-ACS-2345