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Clinical Trials/NCT03731923
NCT03731923
Active, not recruiting
Not Applicable

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

Seoul National University Hospital2 sites in 1 country257 target enrollmentNovember 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatocellular Carcinoma
Sponsor
Seoul National University Hospital
Enrollment
257
Locations
2
Primary Endpoint
Sensitivity for detecting HCC
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 8, 2018
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeong Min Lee

Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sensitivity for detecting HCC

Time Frame: 12 months after last MRI

Sensitivity for detecting HCC

Secondary Outcomes

  • Specificity for detecting HCC(12 months after last MRI)
  • Image quality of abbreviated liver MRI(12 months after last MRI)
  • Table time of abbreviated MRI(1 day after each MRI)
  • In-room time of abbreviated MRI(1 day after each MRI)
  • Sensitivity for detecting early stage HCC(12 months after last MRI)
  • Specificity for detecting early stage HCC(12 months after last MRI)

Study Sites (2)

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