CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CEUS imaging, aMRI imaging.
- Who it may be relevant to
- Registry conditions: HCC, Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Contrast Ultrasound vs. Abbreviated MRI for Detection of HCC in Patients With Indeterminate Liver Nodules
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.
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.
Interventions
- Diagnostic test CEUS imaging
Contrast-enhanced ultrasound (CEUS) - Diagnostic test aMRI imaging
contrast enhanced abbreviated MRI (AMRI)
Primary outcome measures
- Early HCC Detection [Time frame: 5 years]
Secondary outcome measures (2)
- HCC Detection [Time frame: 5 years]
- Early HCC Detection [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- University of Michigan — Ann Arbor
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT06184152 · 1U01CA283935