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

Study Overview
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Brief Summary
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The study will be conducted at the following locations: UT Southwestern Medical Center Parkland Health and Hospital System University of Michigan We will build a phase IV biomarker study, in which we prospectively compare the performance of dynamic contrast enhanced abbreviated MRI (AMRI) and contrast-enhanced ultrasound (CEUS) for early-stage HCC detection in patients with ILNs.

Detailed Description
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We will prospectively perform both AMRI and CEUS in enrolled patients every 3-6 months. Patients with LR3 observations will undergo CEUS and AMRI every 6 months; patients with LR4 observations will undergo CEUS and AMRI 3 months after enrollment and every 6 months thereafter. CEUS and AMRI will preferably be done the same day, although will be permitted to be completed within 14 days of each other. 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.

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

Conditions
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HCC, Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: CEUS vs aMRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CEUS/aMRI<br> | Diagnostic Test: CEUS vs aMRI<br>* Comparison between CEUS and aMRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC Detection | Evaluate TPR and FPR for any-stage HCC. | 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 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LR3, LR4, HCC Surveillance