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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
600
Contrast-enhanced ultrasound (CEUS)
contrast enhanced abbreviated MRI (AMRI)
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGEarly 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.
Time frame: 5 years
HCC Detection
Evaluate TPR and FPR for any-stage HCC.
Time frame: 5 years
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 Milan Criteria
Time frame: 5 years
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