Abbreviated MRI for HCC Surveillance

August 16, 2023 updated by: Jeong Min Lee, Seoul National University Hospital

MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

257

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

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Biannual ultrasonography
Biannual liver ultrasonography for HCC surveillance, without contrast agent.
Other Names:
  • liver USG
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.
Other Names:
  • Abbreviated liver MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity for detecting HCC
Time Frame: 12 months after last MRI
Sensitivity for detecting HCC
12 months after last MRI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Table time of abbreviated MRI
Time Frame: 1 day after each MRI
time from scan start and scan end
1 day after each MRI
In-room time of abbreviated MRI
Time Frame: 1 day after each MRI
interval between participants' walk-in and walk-out times
1 day after each MRI
Specificity for detecting HCC
Time Frame: 12 months after last MRI
Specificity for detecting HCC
12 months after last MRI
Sensitivity for detecting early stage HCC
Time Frame: 12 months after last MRI
Sensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
12 months after last MRI
Specificity for detecting early stage HCC
Time Frame: 12 months after last MRI
Specificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
12 months after last MRI
Image quality of abbreviated liver MRI
Time Frame: 12 months after last MRI
qualitative analysis on four-point scale
12 months after last MRI

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Guerbet

Investigators

  • Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

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)

November 8, 2018

Primary Completion (Actual)

December 15, 2021

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

November 4, 2018

First Submitted That Met QC Criteria

November 4, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2018-1426

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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