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

NCT ID: NCT06184152

Last Updated: 2025-08-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2028-11-28

Brief Summary

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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

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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.

Conditions

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HCC Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Intervention is not masked for study team or investigator but all images are being interpreted by radiologist who is masked to clinical outcomes (development of HCC).

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.

Group Type OTHER

CEUS imaging

Intervention Type DIAGNOSTIC_TEST

Contrast-enhanced ultrasound (CEUS)

aMRI imaging

Intervention Type DIAGNOSTIC_TEST

contrast enhanced abbreviated MRI (AMRI)

Interventions

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CEUS imaging

Contrast-enhanced ultrasound (CEUS)

Intervention Type DIAGNOSTIC_TEST

aMRI imaging

contrast enhanced abbreviated MRI (AMRI)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Amit Singal

Lead Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisa Quirk, MS/MPH

Role: CONTACT

214-645-6179

Sneha Deodhar, MS

Role: CONTACT

214-645-1378

Facility Contacts

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Matthew DeMaio

Role: primary

Lisa Quirk, MS/MPH

Role: primary

Sneha Deodhar, MS

Role: backup

Other Identifiers

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1U01CA283935

Identifier Type: NIH

Identifier Source: org_study_id

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