Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: contrast-enhanced ultrasound; Diagnostic Test: EOB-MRI

• Registration Number: NCT03742453
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-16
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-15
• Primary Completion: 2019-08-26
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepatic nodule group	contrast-enhanced ultrasound	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)
Hepatic nodule group	EOB-MRI	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)

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of CEUS for diagnosing HCC	3 months after CEUS	accuracy, sensitivity, specificity of CEUS for HCC diagnosis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of