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

Phase 4

Recruiting

• Conditions: Liver Cancer; Liver Cirrhoses; Liver Carcinoma
• Interventions: Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

• Registration Number: NCT04288323
• Lead Sponsor: University of California, San Diego

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.

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 Timeline

• Study Start: 2018-04-27
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid	This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam

Primary Outcome Measures

Name	Time	Method
Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection	up to one year	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
Reader reliability of screening modalities	up to 12 months from completion of imaging	the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States