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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06184152
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CEUS imaging — DIAGNOSTIC_TEST
    Contrast-enhanced ultrasound (CEUS)
  • aMRI imaging — DIAGNOSTIC_TEST
    contrast enhanced abbreviated MRI (AMRI)

Study Details

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.

Key Dates

Start date
Nov 28, 2023
Status verified
Apr 2025
Primary completion
Nov 28, 2028
Completion
Nov 28, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: 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.

Primary Outcome Measure

Early HCC Detection [ Time Frame: 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Matthew DeMaio
[email protected]
University of Texas Southwestern Medical CenterDallasTexas75390
Lisa Quirk, MS/MPH
[email protected]
Sneha Deodhar, MS
[email protected]
Amit Singal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Michigan· Ann Arbor, MIUniversity of Texas Southwestern Medical Center· Dallas, TX

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