CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules
NCT ID: NCT06184152
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2023-11-28
2028-11-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ILN Cohort
Patients with LR3 observations would undergo CEUS and AMRI every 6 months; patients with LR4 observations would undergo CEUS and AMRI 3 months after enrollment and every 6 months thereafter. CEUS and AMRI will preferably be done the same day to minimize burden on the patient, although will be permitted to be completed within 14 days of each other. This interval is sufficiently short to minimize the chance of intervening events. AMRI and CEUS 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.
CEUS imaging
Contrast-enhanced ultrasound (CEUS)
aMRI imaging
contrast enhanced abbreviated MRI (AMRI)
Interventions
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CEUS imaging
Contrast-enhanced ultrasound (CEUS)
aMRI imaging
contrast enhanced abbreviated MRI (AMRI)
Eligibility Criteria
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Inclusion Criteria
* Adults 18 years old and above
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Amit Singal
Lead Principal Investigator
Locations
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University of Michigan
Ann Arbor, Michigan, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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