A Study of HCC High Risk Group Using Two Surveillance Tools

Seoul National University Hospital139 enrolled

Overview

The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC.

Patients at high risk of HCC are recommended to undergo biannual surveillance using ultrasound. In this study, LDCT is performed in addition to biannual ultrasound surveillance in eligible patients to compare their sensitivity for HCC. Standard of reference would be follow-up imaging and/or gadoxetic acid-enhanced liver MRI.

Study Type

OBSERVATIONAL

Enrollment

139

Conditions

HCC

Interventions

non-ionic monomer iodinated CT contrast mediaDRUG

patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: All conditions have to be satisfied to be enrolled. * \> 20 years * high risk group of HCC according to AASLD guideline * risk index \> = 2.33 * currently on regular biannual surveillance using ultrasonography * sign informed consent Exclusion Criteria: Patients with any of following condition cannot be enrolled. * previously diagnosed with HCC * any contraindication of contrast enhanced CT including allergic reaction to iodine * history of other malignancy

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Detection rate of patients with HCC

from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening

Time frame: 18 months

Secondary Outcomes

Detection rate of patients with early HCC

from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening

Time frame: 18 months

False referral rate

from the 1st LDCT/US screening to six months follow-up after last (12 month after 1st LDCT/US) LDCT/US screening

Time frame: 18 months

Data from ClinicalTrials.gov

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