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

NCT ID: NCT04288323

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-27
• Study Completion Date: 2025-12-30

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.

Conditions

Liver Cancer; Liver Cirrhoses; Liver Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: EXPERIMENTAL

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

Intervention Type: DRUG

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

Interventions

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Claude Sirlin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claude B Sirlin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexandra Schlein

Role: CONTACT

a1schlein@health.ucsd.edu

(858) 246- 2199

Yesenia Covarrubias

Role: CONTACT

ycovarrubias@health.ucsd.edu

(858) 246 - 2198

Other Identifiers

171769

Identifier Type: -

Identifier Source: org_study_id