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

Last updated: February 10, 2026
Sponsor: University of California, San Diego
Overall Status: Completed

Phase

4

Condition

Hepatic Fibrosis

Digestive System Neoplasms

Liver Cancer

Treatment

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

Clinical Study ID

NCT04288323
171769
  • Ages > 18
  • All Genders

Study Summary

This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has been fully informed and has personally signed and dated the writtenInformed Consent and Health Insurance Portability and Accountability Act (HIPAA)documents.

  • Adult subjects of any gender and any ethnic group with liver cirrhosis of anyetiology,

  • Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection ifneeded, research AMRI exam, research US exam) and the three optional surveys (ifsubject opts in for that) within specified time windows, and is willing to allow thestudy team to review clinical data including but not limited to other clinicalradiology reports and images.

Exclusion

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 administrationof Eovist*

  • Clinical screening exam of the liver performed at UCSD within the prior 90 days toconsent

Study Design

Total Participants: 79
Treatment Group(s): 1
Primary Treatment: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
Phase: 4
Study Start date:
April 27, 2018
Estimated Completion Date:
December 16, 2025

Study Description

Ultrasound (US) is currently used for HCC surveillance. However, US has certain limitations, so physicians use contrast CT or MRI. However, these are expensive and time-consuming procedures. We introduced an abbreviated MRI (AMRI) exam, which works well in cirrhotic and obese patients (unlike US), involves no ionizing radiation (unlike CT), and is rapid (unlike multi-phasic MRI) with total scanner times of less than ten minutes, and can be performed at about the same cost as US. This study in adult patients with cirrhosis will compare the performance of AMRI vs. US for detection of early-stage disease, and will help to define and validate a novel, rapid, accurate, and potentially cost-effective imaging protocol for HCC screening in high-risk individuals.

Connect with a study center

  • University of California, San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • University of California, San Diego

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.