Abbreviated MRI for HCC Surveillance

NCT ID: NCT03731923

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hepatocellular Carcinoma Liver Cirrhosis Chronic Hepatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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High risk group of HCC

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

Group Type EXPERIMENTAL

Biannual ultrasonography

Intervention Type DIAGNOSTIC_TEST

Biannual liver ultrasonography for HCC surveillance, without contrast agent.

Annual abbreviated liver MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Biannual ultrasonography

Biannual liver ultrasonography for HCC surveillance, without contrast agent.

Intervention Type DIAGNOSTIC_TEST

Annual abbreviated liver MRI

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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liver USG Abbreviated liver MRI

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* history of HCC
* congestive hepatopathy
* iron deposition
* any absolute or relative contra-indication of contrast-enhanced MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-2018-1426

Identifier Type: -

Identifier Source: org_study_id

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