This trial is active, not recruiting.

Condition hcc
Treatment non-ionic monomer iodinated ct contrast media
Sponsor Seoul National University Hospital
Collaborator Taejoon Pharm Co., Ltd.
Start date November 2014
End date July 2017
Trial size 139 participants
Trial identifier NCT02675920, SNUH-2013-2284


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.
non-ionic monomer iodinated ct contrast media contrast enhanced CT
patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)

Primary Outcomes

Detection rate of patients with HCC
time frame: 18 months

Secondary Outcomes

Detection rate of patients with early HCC
time frame: 18 months
False referral rate
time frame: 18 months

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Principal investigator Jeong Min Lee, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.