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

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.

Study Overview

• Status: Completed
• Conditions: HCC
• Intervention / Treatment: Drug: non-ionic monomer iodinated CT contrast media

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.

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients at high risk of HCC AND High Risk Index (>=2.33)

Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus [HCV] or hepatitis B surface antigen [HBsAg] is positive).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

High risk group of HCC; known high risk group of HCC according to AASLD guideline. And patients whose risk index is equal to or higher than 2.33. Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus [HCV] or hepatitis B surface antigen [HBsAg] is positive). Patients undergo ultrasonography and LDCT using non-ionic monomer iodinated CT contrast media biannually and the interval between ultrasound and LDCT is within 30 days.

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); Other Names: contrast enhanced CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Taejoon Pharmaceutical Co., Ltd.; Reyon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2014
• Primary Completion (Actual): January 11, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: ultrasonography; computed tomography; surveillance
• Other Study ID Numbers: SNUH-2013-2284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No