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

Seoul National University Hospital1 site in 1 country117 target enrollmentOctober 16, 2018

ConditionsHepatocellular Carcinoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Seoul National University Hospital
Enrollment: 117
Locations: 1
Primary Endpoint: Diagnostic performance of CEUS for diagnosing HCC
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 16, 2018

End Date

December 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jeong Min Lee

Professor

Seoul National University Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Diagnostic performance of CEUS for diagnosing HCC

Time Frame: 3 months after CEUS

accuracy, sensitivity, specificity of CEUS for HCC diagnosis

Secondary Outcomes

Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018(3 months after MRI)
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018(3 months after MRI)