NCT06184152

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCC
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CEUS imaging	Contrast-enhanced ultrasound (CEUS)
DIAGNOSTIC_TEST	aMRI imaging	contrast enhanced abbreviated MRI (AMRI)

Timeline

• Start date: 2023-11-28
• Primary completion: 2028-11-28
• Completion: 2028-11-28
• First posted: 2023-12-28
• Last updated: 2025-08-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study