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NCT03731923 Clinical Trial

Abbreviated MRI for HCC Surveillance

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03731923
Other study ID # SNUH-2018-1426
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 8, 2018
Est. completion date December 31, 2023

Study information
Verified date August 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 257
Est. completion date December 31, 2023
Est. primary completion date December 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Biannual ultrasonography
Biannual liver ultrasonography for HCC surveillance, without contrast agent.
• 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.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital Guerbet

Country where clinical trial is conducted

Korea, Republic of, 

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