Recruiting

CEUS vs. AMRI

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06184152

Conditions

HCC

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CEUS imaging

aMRI imaging

Study Details

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.

Conditions

HCC

Hepatocellular Carcinoma

Study ID

NCT06184152

Start date

Nov 28, 2023

Status verified date

Jun, 2026

Completion date

Nov 28, 2028

Anticipated

Primary completion date

Nov 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

CEUS imaging

Contrast-enhanced ultrasound (CEUS)

aMRI imaging

contrast enhanced abbreviated MRI (AMRI)

Primary outcome measure

  • Early HCC Detection [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Lisa Quirk, MS/MPH

214-645-6179lisa.quirk@utsouthwestern.edu

Sneha Deodhar, MS

214-645-1378sneha.deodhar@utsouthwestern.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Matthew DeMaio

demaioma@med.umich.edu

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Lisa Quirk, MS/MPH

lisa.quirk@utsouthwestern.edu

Sneha Deodhar, MS

sneha.deodhar@utsouthwestern.edu

Principal Investigator:

Amit Singal, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • LR3
  • LR4
  • HCC Surveillance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-02.