NCT06184152NARecruiting

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

University of Texas Southwestern Medical Center

Start Date

11/28/2023

Completion Date

11/28/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

CEUS imaging

DIAGNOSTIC_TEST

aMRI imaging

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

HCCHepatocellular Carcinoma

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States