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

Not Applicable

Recruiting

• Conditions: HCC; Hepatocellular Carcinoma
• Interventions: Diagnostic Test: CEUS imaging; Diagnostic Test: aMRI imaging

• 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: 2025-04-15
• Last Update Posted: 2025-04-16
• 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

Arm && Interventions

Group	Intervention	Description
ILN Cohort	CEUS imaging	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.
ILN Cohort	aMRI imaging	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.

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