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Abbreviated MRI for HCC Surveillance

Sponsor
Seoul National University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03731923
Collaborator
Guerbet (Industry)
257
Enrollment
2
Locations
1
Arm
57.7
Anticipated Duration (Months)
128.5
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Biannual ultrasonography
  • Diagnostic Test: Annual abbreviated liver MRI
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
257 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group
Actual Study Start Date :
Nov 8, 2018
Actual Primary Completion Date :
Dec 15, 2021
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity for detecting HCC [12 months after last MRI]

      Sensitivity for detecting HCC

    Secondary Outcome Measures

    1. Table time of abbreviated MRI [1 day after each MRI]

      time from scan start and scan end

    2. In-room time of abbreviated MRI [1 day after each MRI]

      interval between participants' walk-in and walk-out times

    3. Specificity for detecting HCC [12 months after last MRI]

      Specificity for detecting HCC

    4. Sensitivity for detecting early stage HCC [12 months after last MRI]

      Sensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)

    5. Specificity for detecting early stage HCC [12 months after last MRI]

      Specificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)

    6. Image quality of abbreviated liver MRI [12 months after last MRI]

      qualitative analysis on four-point scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of
    2 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital
    • Guerbet

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeong Min Lee, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03731923
    Other Study ID Numbers:
    • SNUH-2018-1426
    First Posted:
    Nov 6, 2018
    Last Update Posted:
    Dec 23, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jeong Min Lee, Professor, Seoul National University Hospital
    MRI
    ultrasonography
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Liver Extracts

    Study Results

    No Results Posted as of Dec 23, 2021