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Recruiting

NCT Number: NCT06184152

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEUS imaging

Diagnostic Test

Contrast-enhanced ultrasound (CEUS)

aMRI imaging

Diagnostic Test

contrast enhanced abbreviated MRI (AMRI)

Primary outcomes

  1. Early HCC Detection

    Time frame: 5 years

    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.

Secondary outcomes

  1. HCC Detection

    Time frame: 5 years

    Evaluate TPR and FPR for any-stage HCC.

  2. Early HCC Detection

    Time frame: 5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Quirk, MS/MPH

CONTACT

[email protected]

214-645-6179

Sneha Deodhar, MS

CONTACT

[email protected]

214-645-1378

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • University of Michigan

Registry information

Official study title

Contrast Ultrasound vs. Abbreviated MRI for Detection of HCC in Patients With Indeterminate Liver Nodules

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 28, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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