Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

March 16, 2021 updated by: Jeong Min Lee, Seoul National University Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hepatic nodule group
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
CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.
Other Names:
  • CEUS
Diagnostic test: EOB-MRI
EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.
Other Names:
  • gadoxetic acid MRI
  • Gd-EOB-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of CEUS for diagnosing HCC
Time Frame: 3 months after CEUS
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
Time Frame: 3 months after MRI
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
Time Frame: 3 months after MRI
accuracy, sensitivity, specificity of MRI using KLCSG-NCC guideline v2018 for HCC diagnosis
3 months after MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Bracco Corporate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

August 26, 2019

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2018-2268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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