Health TrialsbyHealthPanel

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

ConditionsHCCHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • CEUS imaging

    Diagnostic test

    Contrast-enhanced ultrasound (CEUS)

  • aMRI imaging

    Diagnostic test

    contrast enhanced abbreviated MRI (AMRI)

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: ILN CohortOther 2 interventions

Trial outcomes

Primary outcomes

1

Early HCC Detection

Assess and compare true positive rate (TPR) and false positive rate (FPR) of AMRI to CEUS for early-stage HCC detection, as defined by the Barcelona Clinic Liver Staging system.

Time frame
5 years

Secondary outcomes

1

HCC Detection

Evaluate TPR and FPR for any-stage HCC.

Time frame
5 years
2

Early HCC Detection

Assess and compare true positive rate (TPR) and false positive rate (FPR) of AMRI to CEUS for early-stage HCC detection, as defined by the Milan Criteria

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

University of Michigan

Collaborator

Source ClinicalTrials.gov
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