Alternative Surveillance Program for Patients With High Risk Group of HCC

Not Applicable

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: Non-contrast focused MRI

• Registration Number: NCT05657249
• Lead Sponsor: Seoul National University Hospital

Brief Summary

In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-10
• Study First Submitted QC: 2022-12-10
• Study First Posted: 2022-12-20
• Study Start: 2023-01-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-02-28
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• chronic hepatitis B or C
• Child-Pugh classification A
• HCC risk score >= -2.04
• have not diagnosed with HCC
• on surveillance program using US and negative on previous US within 6-8 months of enrollment
• sign informed consent

Exclusion Criteria

• younger than 40 years or older than 70 years old
• history of HCC
• severe GFR or on HD/PD due to renal failure
• contra-indication of MRI
• congestive hepatopathy
• iron deposition
• pregnancy or nursing mother
• non-viral hepatitis or liver cirrhosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
US & MRI	Non-contrast focused MRI	All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI.

Primary Outcome Measures

Name	Time	Method
Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection	up to one year	per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.

Secondary Outcome Measures

Name	Time	Method
diagnostic yield for HCC	up to one year	HCC incidence in the group and detection rate with either US or focused MRI
Comparison of annual focused MRI and biannual US for HCC detection	up to one year	per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
scan time of focused MRI	up to one month	in room time, table time are manually recorded
comparison between false referral rates of biannual US and annual focused MRI	up to one year	comparison between false positive report/finding for HCC in each surveillance modality.

Trial Locations

Locations (1)

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