Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03742453
• Other study ID #: SNUH-2018-2268
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: December 31, 2021
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• contrast-enhanced ultrasound
CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.
• EOB-MRI
EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bracco Corporate

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of CEUS for diagnosing HCC	accuracy, sensitivity, specificity of CEUS for HCC diagnosis	3 months after CEUS
Secondary	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
Secondary	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