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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

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 details
    HCC
    Hepatocellular Carcinoma

NCT06184152

University of Texas Southwestern Medical Center

27 January 2024

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