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

NCT04288323 | Completed Phase 4 FDA Drug

• 1 other identifier: 171769
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Carcinoma; Liver Cancer; Liver Cirrhoses

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam

Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

Interventions

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid DRUG

This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Claude B Sirlin, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: April 27, 2018
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)