A Study of HCC High Risk Group Using Two Surveillance Tools

Seoul National University

Status: Completed

Conditions: HCC

Treatments: Drug: non-ionic monomer iodinated CT contrast media

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02675920

SNUH-2013-2284

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

139 participants in 1 patient group

High risk group of HCC

Description:

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.

Treatment:

Drug: non-ionic monomer iodinated CT contrast media