Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

Seoul National University

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Diagnostic Test: contrast-enhanced ultrasound; Diagnostic Test: EOB-MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03742453

SNUH-2018-2268

Details and patient eligibility

About

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).

Enrollment: 117 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

Hepatic nodule group

Experimental group

Description:

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)

Treatment:

Diagnostic Test: EOB-MRI

Diagnostic Test: contrast-enhanced ultrasound