Alternative Surveillance Program for Patients With High Risk Group of HCC

N/AActive Not RecruitingNCT05657249

Seoul National University Hospital199 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

199

Conditions

Hepatocellular Carcinoma

Interventions

Non-contrast focused MRIDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.

Time frame: up to one year

Secondary Outcomes

Comparison of annual focused MRI and biannual US for HCC detection

per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.

Time frame: up to one year

diagnostic yield for HCC

HCC incidence in the group and detection rate with either US or focused MRI

Time frame: up to one year

scan time of focused MRI

in room time, table time are manually recorded

Time frame: up to one month

comparison between false referral rates of biannual US and annual focused MRI

comparison between false positive report/finding for HCC in each surveillance modality.

Time frame: up to one year

Data from ClinicalTrials.gov

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