Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

Study Overview
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Brief Summary
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This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).

Official Title
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Evaluation of Diagnostic Accuracy of Contrast-enhanced Ultrasound (CEUS) and Gadoxetic Acid-enhanced Liver MRI for Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: contrast-enhanced ultrasound
* Diagnostic Test: EOB-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk group of developing HCC hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT) newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year scheduled for gadoxetic acid-enhanced liver MRI signed informed consent Exclusion Criteria: hypersensitivity for ultrasound contrast media pregnancy history of recent treatment for HCC in a year standard of reference is not available severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatic nodule group<br>This group meets eligibility criteria, and undergo contrast-enhanced ultrasound (CEUS) and scheduled gadoxetic acid MRI (gadoxetic acid-enhanced liver MRI; EOB-MRI; Gd-EOB-MRI) | Diagnostic Test: contrast-enhanced ultrasound<br>* CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.<br>* Other names: CEUS;Diagnostic Test: EOB-MRI<br>* EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.<br>* Other names: Gd-EOB-MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of CEUS for diagnosing HCC | accuracy, sensitivity, specificity of CEUS for HCC diagnosis | 3 months after CEUS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018 | accuracy, sensitivity, specificity of MRI using LI-RADS v2018 for HCC diagnosis | 3 months after MRI | 
| Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018 | accuracy, sensitivity, specificity of MRI using KLCSG-NCC guideline v2018 for HCC diagnosis | 3 months after MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CEUS, gadoxetic acid, MRI