Alternative Surveillance Program for Patients With High Risk Group of HCC

NCT ID: NCT05657249

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-06
• Study Completion Date: 2026-12-31

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

US & MRI

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

Group Type: EXPERIMENTAL

Non-contrast focused MRI

Intervention Type: DIAGNOSTIC_TEST

non-contrast liver MRI focusing on HCC surveillance in a short scan time.

Interventions

Non-contrast focused MRI

non-contrast liver MRI focusing on HCC surveillance in a short scan time.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Focused MRI; Abbreviated MRI

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

The Catholic University of Korea

OTHER

Sponsor Role: collaborator

Korea University Guro Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Hee Yoon

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Hee Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUH-2021-1084

Identifier Type: -

Identifier Source: org_study_id