Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

June 22, 2024 updated by: Dong Ho Lee, Seoul National University Hospital

The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study

This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a prospective single-arm intra-individual comparison multicenter study

Study Type

Observational

Enrollment (Actual)

210

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, 03080
        • Seoul National University Hospital
    • Korea (the Republic Of)
      • Seongnam, Korea (the Republic Of), Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea (the Republic Of), Korea, Republic of, 05505
        • Asan Medical Center

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

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent curative treatment for HCC including surgical resection or local ablation and have a more than a two-year disease-free period, needing continuous surveillance for the development of HCC will be candidates for this study.

Description

Inclusion Criteria:

  • Age between 20-year old and 85-year old
  • Patients with a history of curative treatment for HCC including surgical resection or local ablation
  • No recurrence after curative treatment of HCC for more than two years
  • Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)

Exclusion Criteria:

  • Estimated GFR less than 60
  • Previous history of severe allergic reaction to the iodinated contrast agent
  • Patients with claustrophobia who can't undergo MR examination
  • Patients having cochlear implants or cardiac pacemaker

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy per patient
Time Frame: Within 6 months from the study completion
Accuracy for detection of recurrent HCC per patient
Within 6 months from the study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity per patient
Time Frame: Within 6 months from the study completion
Specificity for detection of recurrent HCC per patient
Within 6 months from the study completion
Sensitivity per patient
Time Frame: Within 6 months from the study completion
Sensitivity for detection of recurrent HCC per patient
Within 6 months from the study completion

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Dong Ho Lee, M.D., 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)

December 28, 2021

Primary Completion (Actual)

June 22, 2024

Study Completion (Actual)

June 22, 2024

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 22, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2106-183-1230
  • KCT0006395 (Registry Identifier: https://cris.nih.go.kr/)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) of this study will be available for reasonable requests after approval of IRB

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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