A Study of HCC High Risk Group Using Two Surveillance Tools

HCC Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675920
• Other study ID #: SNUH-2013-2284
• Status: Completed
• Start date: November 28, 2014
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 1, 2019
• Est. primary completion date: January 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HCC

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Reyon Pharmaceutical Co., Ltd., Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	radiation dose per patient	from the 1st LDCT/US screening to last LDCT/US screening	12 months
Primary	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	18 months
Secondary	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	18 months
Secondary	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	18 months