NCT03731923

Brief Summary

This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group.

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
257

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

November 8, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

November 4, 2018

Last Update Submit

August 16, 2023

Conditions

Hepatocellular CarcinomaLiver CirrhosisChronic Hepatitis

Keywords

MRIultrasonography

Outcome Measures

Primary Outcomes (1)

  • Sensitivity for detecting HCC

    Sensitivity for detecting HCC

    12 months after last MRI

Secondary Outcomes (6)

  • Table time of abbreviated MRI

    1 day after each MRI

  • In-room time of abbreviated MRI

    1 day after each MRI

  • Specificity for detecting HCC

    12 months after last MRI

  • Sensitivity for detecting early stage HCC

    12 months after last MRI

  • Specificity for detecting early stage HCC

    12 months after last MRI

  • +1 more secondary outcomes

Study Arms (1)

High risk group of HCC

EXPERIMENTAL

High risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI.

Diagnostic Test: Biannual ultrasonographyDiagnostic Test: Annual abbreviated liver MRI

Interventions

Biannual ultrasonographyDIAGNOSTIC_TEST

Biannual liver ultrasonography for HCC surveillance, without contrast agent.

Also known as: liver USG
High risk group of HCC
Annual abbreviated liver MRIDIAGNOSTIC_TEST

Abbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes.

Also known as: Abbreviated liver MRI
High risk group of HCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high risk of HCC development (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
  • no history of HCC
  • on surveillance of HCC using ultrasonography
  • sign informed consent

You may not qualify if:

  • history of HCC
  • congestive hepatopathy
  • iron deposition
  • any absolute or relative contra-indication of contrast-enhanced MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver CirrhosisHepatitis, Chronic

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitisChronic DiseaseDisease Attributes

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
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 6, 2018

Study Start

November 8, 2018

Primary Completion

December 15, 2021

Study Completion

December 31, 2023

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)