Skip to main content
OpenTrials
Completed

NCT Number: NCT02675920

A Study of HCC High Risk Group Using Two Surveillance Tools

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HCC

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-ionic monomer iodinated CT contrast media

Drug

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

Other names: contrast enhanced CT

Primary outcomes

  1. Detection rate of patients with HCC

    Time frame: 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 outcomes

  1. Detection rate of patients with early HCC

    Time frame: 18 months

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

  2. False referral rate

    Time frame: 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 outcomes

  1. radiation dose per patient

    Time frame: 12 months

    from the 1st LDCT/US screening to last LDCT/US screening

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Reyon Pharmaceutical Co., Ltd.
  • Taejoon Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2016
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.