Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) Vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients with Cirrhosis

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Feb 25, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for checking for liver cancer (called Hepatocellular Carcinoma or HCC) in people who have liver cirrhosis, which is a serious liver condition. The trial compares a special type of MRI, known as gadolinium contrast-enhanced Abbreviated MRI (AMRI), to the standard ultrasound that is commonly used for these checks. The goal is to see which method is better at detecting liver cancer early.

To participate in this study, you need to be an adult (18 years or older) with liver cirrhosis. You should not have a history of liver cancer or be pregnant, among other criteria. If you join the study, you will undergo both the MRI and the ultrasound, as well as some additional surveys if you choose to participate in them. This trial is currently recruiting participants, so if you’re interested or think you might qualify, it's a good idea to talk to your doctor for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents.
• • Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology,
• • Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research AMRI exam, research US exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images.
• Exclusion Criteria:
• • VA patient
• • \< 18 years of age
• • History of any liver cancer
• • MRI contraindication(s)
• • Subject knows that she is pregnant or states she trying to become pregnant
• • Positive urine pregnancy test in woman of childbearing potential
• • Nursing mother
• • Subject has known allergy to any gadolinium agent
• • Does not meet UC San Diego Intravenous Contrast Media Guidelines for administration of Eovist\*
• • Clinical screening exam of the liver performed at UCSD within the prior 90 days to consent