Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC

Seoul National University Hospital1 site in 1 country199 target enrollmentJanuary 6, 2023

ConditionsHepatocellular Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Seoul National University Hospital
Enrollment: 199
Locations: 1
Primary Endpoint: Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 6, 2023

End Date

December 31, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jeong Hee Yoon

Clinical Professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection

Time Frame: 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 Outcomes

diagnostic yield for HCC(up to one year)
Comparison of annual focused MRI and biannual US for HCC detection(up to one year)
scan time of focused MRI(up to one month)
comparison between false referral rates of biannual US and annual focused MRI(up to one year)