NCT06184152

Brief Summary

The study will be conducted at the following locations:

  1. 1.UT Southwestern Medical Center
  2. 2.Parkland Health and Hospital System
  3. 3.University of Michigan

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Nov 2023Nov 2028

Study Start

First participant enrolled

November 28, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2028

Last Updated

August 5, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

December 4, 2023

Last Update Submit

August 1, 2025

Conditions

HCCHepatocellular Carcinoma

Keywords

LR3LR4HCC Surveillance

Outcome Measures

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.

    5 years

Secondary Outcomes (2)

  • HCC Detection

    5 years

  • Early HCC Detection

    5 years

Study Arms (1)

ILN Cohort

OTHER

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.

Diagnostic Test: CEUS imagingDiagnostic Test: aMRI imaging

Interventions

CEUS imagingDIAGNOSTIC_TEST

Contrast-enhanced ultrasound (CEUS)

ILN Cohort
aMRI imagingDIAGNOSTIC_TEST

contrast enhanced abbreviated MRI (AMRI)

ILN Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Lisa Quirk, MS/MPH

CONTACT

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

Sneha Deodhar, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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).
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Principal Investigator

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 28, 2023

Study Start

November 28, 2023

Primary Completion (Estimated)

November 28, 2028

Study Completion (Estimated)

November 28, 2028

Last Updated

August 5, 2025

Record last verified: 2025-04

Locations

US(2)