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

University of California San Diego

Status and phase: Enrolling; Phase 4

Conditions: Liver Cirrhoses; Liver Carcinoma; Liver Cancer

Treatments: Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04288323

171769

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Single arm

Experimental group

Description:

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

Treatment:

Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid