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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Lisa Quirk, MS/MPH
lisa.quirk@utsouthwestern.edu
214-645-6179
Backup
Sneha Deodhar, MS
sneha.deodhar@utsouthwestern.edu
214-645-1378
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2028-11-28
Participants
Target number of participants: 600
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Michigan
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov