A Study of HCC High Risk Group Using Two Surveillance Tools

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Cohort Study to Compare Contrast Enhanced Liver CT and Ultrasonography for Hepatocellular Carcinoma Surveillance in High-risk Group of HCC: Preliminary Study

Conditions
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HCC

Intervention / Treatment
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* Drug: non-ionic monomer iodinated CT contrast media


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk group of HCC<br>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<br>* patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)<br>* Other names: contrast enhanced CT;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surveillance, ultrasonography, computed tomography