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| Name | Class |
|---|---|
| Taejoon Pharmaceutical Co., Ltd. | INDUSTRY |
| Reyon Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-ionic monomer iodinated CT contrast media | Drug | patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media) |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| radiation dose per patient | from the 1st LDCT/US screening to last LDCT/US screening | 12 months |
Inclusion Criteria:
All conditions have to be satisfied to be enrolled.
Exclusion Criteria:
Patients with any of following condition cannot be enrolled.
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| 18 months |