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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06184152

Enrollment

600

Registered

2023-12-28

Start date

2023-11-28

Completion date

2028-11-28

Last updated

2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC, Hepatocellular Carcinoma

Keywords

LR3, LR4, HCC Surveillance

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTCEUS imaging

Contrast-enhanced ultrasound (CEUS)

DIAGNOSTIC_TESTaMRI imaging

contrast enhanced abbreviated MRI (AMRI)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

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).

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Early HCC Detection	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

Measure	Time frame	Description
HCC Detection	5 years	Evaluate TPR and FPR for any-stage HCC.
Early HCC Detection	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

Countries

United States

Contacts

CONTACTLisa Quirk, MS/MPH

lisa.quirk@utsouthwestern.edu214-645-6179

CONTACTSneha Deodhar, MS

sneha.deodhar@utsouthwestern.edu214-645-1378

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026