A Study of HCC High Risk Group Using Two Surveillance Tools

Completed

• Conditions: HCC
• Interventions: Drug: non-ionic monomer iodinated CT contrast media

• Registration Number: NCT02675920
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2014-11-28
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-05
• Primary Completion: 2019-01-11
• Study Completion: 2019-10-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk group of HCC	non-ionic monomer iodinated CT contrast media	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of