Status:
RECRUITING
CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
University of Michigan
Conditions:
HCC
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06184152
Start Date
November 28 2023
End Date
November 28 2028
Last Update
August 5 2025
Active Locations (2)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390