NCT03742453

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

November 13, 2018

Last Update Submit

March 16, 2021

Conditions

Hepatocellular Carcinoma

Keywords

CEUSgadoxetic acidMRI

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of CEUS for diagnosing HCC

    accuracy, sensitivity, specificity of CEUS for HCC diagnosis

    3 months after CEUS

Secondary Outcomes (2)

  • Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018

    3 months after MRI

  • Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018

    3 months after MRI

Study Arms (1)

Hepatic nodule group

EXPERIMENTAL

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 ultrasoundDiagnostic Test: EOB-MRI

Interventions

contrast-enhanced ultrasoundDIAGNOSTIC_TEST

CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.

Also known as: CEUS
Hepatic nodule group
EOB-MRIDIAGNOSTIC_TEST

EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.

Also known as: gadoxetic acid MRI, Gd-EOB-MRI
Hepatic nodule group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 15, 2018

Study Start

October 16, 2018

Primary Completion

August 26, 2019

Study Completion

December 31, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)