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

Abbreviated MRI (AMRI) vs. Ultrasound for HCC Surveillance in Cirrhosis

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

Study Overview

• Status: Completed
• Conditions: Liver Cancer; Liver Carcinoma; Liver Cirrhoses
• Intervention / Treatment: Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam	Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid; This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection	per-patient sensitivity, specificity, positive predictive (PPV), negative predictive value (NPV) and accuracy of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening	up to one year
Reader reliability of screening modalities	the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening	up to 12 months from completion of imaging

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Icahn School of Medicine at Mount Sinai; Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
• Investigators: Principal Investigator: Claude B Sirlin, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2018
• Primary Completion (Actual): December 16, 2025
• Study Completion (Actual): December 16, 2025

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antidotes; Anticoagulants; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Calcium Chelating Agents; Nitric Oxide Donors; gadolinium ethoxybenzyl DTPA
• Other Study ID Numbers: 171769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No