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 ParticipationWhile 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 yourdoctor 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