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Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
contrast-enhanced ultrasound
EOB-MRI
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring CEUS, gadoxetic acid, MRI

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepatic nodule group

Arm 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)

Outcomes

Primary Outcome Measures

Diagnostic performance of CEUS for diagnosing HCC
accuracy, sensitivity, specificity of CEUS for HCC diagnosis

Secondary Outcome Measures

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
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

Full Information

First Posted
November 13, 2018
Last Updated
March 16, 2021
Sponsor
Seoul National University Hospital
Collaborators
Bracco Corporate
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1. Study Identification

Unique Protocol Identification Number
NCT03742453
Brief Title
Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Bracco Corporate

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
CEUS, gadoxetic acid, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepatic nodule group
Arm Type
Experimental
Arm 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)
Intervention Type
Diagnostic Test
Intervention Name(s)
contrast-enhanced ultrasound
Other Intervention Name(s)
CEUS
Intervention Description
CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
EOB-MRI
Other Intervention Name(s)
gadoxetic acid MRI, Gd-EOB-MRI
Intervention Description
EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.
Primary Outcome Measure Information:
Title
Diagnostic performance of CEUS for diagnosing HCC
Description
accuracy, sensitivity, specificity of CEUS for HCC diagnosis
Time Frame
3 months after CEUS
Secondary Outcome Measure Information:
Title
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018
Description
accuracy, sensitivity, specificity of MRI using LI-RADS v2018 for HCC diagnosis
Time Frame
3 months after MRI
Title
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018
Description
accuracy, sensitivity, specificity of MRI using KLCSG-NCC guideline v2018 for HCC diagnosis
Time Frame
3 months after MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

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