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

Not Applicable

Recruiting

• Conditions: HCC; Hepatocellular Carcinoma

• Registration Number: NCT06184152
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2023-11-28
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-05
• Primary Completion: 2028-11-28
• Study Completion: 2028-11-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Early HCC Detection	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.

Secondary Outcome Measures

Name	Time	Method
HCC Detection	5 years	Evaluate TPR and FPR for any-stage HCC.
Early HCC Detection	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

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States