Abbreviated MRI for HCC Surveillance

Not Applicable

Active, not recruiting

• Conditions: Chronic Hepatitis; Hepatocellular Carcinoma; Liver Cirrhosis
• Interventions: Diagnostic Test: Biannual ultrasonography; Diagnostic Test: Annual abbreviated liver MRI

• Registration Number: NCT03731923
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-04
• Study First Submitted QC: 2018-11-04
• Study First Posted: 2018-11-06
• Study Start: 2018-11-08
• Primary Completion: 2021-12-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 257

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High risk group of HCC	Biannual ultrasonography	High risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI.
High risk group of HCC	Annual abbreviated liver MRI	High risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI.

Primary Outcome Measures

Name	Time	Method
Sensitivity for detecting HCC	12 months after last MRI	Sensitivity for detecting HCC

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of