Alternative Surveillance Program for Patients With High Risk Group of HCC

Seoul National University

Status: Active, not recruiting

Conditions: Hepatocellular Carcinoma

Treatments: Diagnostic Test: Non-contrast focused MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05657249

SNUH-2021-1084

Details and patient eligibility

About

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

Enrollment: 199 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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199 participants in 1 patient group

US & MRI

Experimental group

Description:

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

Treatment:

Diagnostic Test: Non-contrast focused MRI