A Study of HCC High Risk Group Using Two Surveillance Tools

A Prospective Cohort Study to Compare Contrast Enhanced Liver CT and Ultrasonography for Hepatocellular Carcinoma Surveillance in High-risk Group of HCC: Preliminary Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02675920

Enrollment

139

Registered

2016-02-05

Start date

2014-11-28

Completion date

2019-10-01

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC

Keywords

surveillance, ultrasonography, computed tomography

Brief summary

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.

Detailed description

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.

Interventions

DRUGnon-ionic monomer iodinated CT contrast media

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Detection rate of patients with HCC	18 months	from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening

Secondary

Measure	Time frame	Description
Detection rate of patients with early HCC	18 months	from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening
False referral rate	18 months	from the 1st LDCT/US screening to six months follow-up after last (12 month after 1st LDCT/US) LDCT/US screening

Other

Measure	Time frame	Description
radiation dose per patient	12 months	from the 1st LDCT/US screening to last LDCT/US screening

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026