CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules

August 1, 2025 updated by: Amit Singal, University of Texas Southwestern Medical Center

Contrast Ultrasound vs. Abbreviated MRI for Detection of HCC in Patients With Indeterminate Liver Nodules

The study will be conducted at the following locations:

  1. UT Southwestern Medical Center
  2. Parkland Health and Hospital System
  3. University of Michigan

Investigators will prospectively compare the performance of dynamic contrast enhanced abbreviated MRI (AMRI) and contrast-enhanced ultrasound for early-stage HCC detection in patients with indeterminate liver nodules.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators will prospectively perform both abbreviated MRI and contrast-enhanced ultrasound in enrolled patients every 3-6 months. Contrast-enhanced ultrasound and abbreviated MRI will preferably be done the same day, although will be permitted to be completed within 30 days of each other. Abbreviated MRI and contrast-enhanced ultrasound will be performed every 3-6 months until HCC development, regression to LR-1 or LR-2 (i.e., definitely or likely benign, respectively), or end of follow-up at 24 months post-enrollment.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Patients with cirrhosis and indeterminate liver nodules (ILN).

Description

Inclusion Criteria:

  • Child A or B cirrhosis from any etiology with at least one ILN on 4-phase CT, contrast- enhanced MRI, or contrast enhanced US but without HCC at baseline.
  • Adults 18 years old and above

Exclusion Criteria:

  • Patients post liver transplantation
  • Patients with concurrent or prior HCC (LR-5 or biopsy proven)
  • other liver cancer including cholangiocarcinoma
  • Patients with any active extra-hepatic malignancy
  • Patients with significant comorbidity and limited life expectancy, e.g., stage D congestive heart failure, in whom surveillance is not warranted are also excluded given unlikely clinical benefit
  • Patients with contraindication to contrast-enhanced MRI or CEUS, including implanted medical devices that are considered MR unsafe and severe claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ILN Cohort
Patients with LR3 observations would undergo CEUS and AMRI every 6 months; patients with LR4 observations would undergo CEUS and AMRI 3 months after enrollment and every 6 months thereafter. CEUS and AMRI will preferably be done the same day to minimize burden on the patient, although will be permitted to be completed within 14 days of each other. This interval is sufficiently short to minimize the chance of intervening events. AMRI and CEUS will be performed every 3-6 months until HCC development, regression to LR-1 or LR-2 (i.e., definitely or likely benign, respectively), or end of follow-up at 24 months post-enrollment.
Diagnostic test: CEUS imaging
Contrast-enhanced ultrasound (CEUS)
Diagnostic test: aMRI imaging
contrast enhanced abbreviated MRI (AMRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early HCC Detection
Time Frame: 5 years
Assess and compare true positive rate (TPR) and false positive rate (FPR) of AMRI to CEUS for early-stage HCC detection, as defined by the Barcelona Clinic Liver Staging system.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCC Detection
Time Frame: 5 years
Evaluate TPR and FPR for any-stage HCC.
5 years
Early HCC Detection
Time Frame: 5 years
Assess and compare true positive rate (TPR) and false positive rate (FPR) of AMRI to CEUS for early-stage HCC detection, as defined by the Milan Criteria
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Estimated)

November 28, 2028

Study Completion (Estimated)

November 28, 2028

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1U01CA283935 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HCC

Clinical Trials on CEUS imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe