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| Name | Class |
|---|---|
| Bracco Corporate | INDUSTRY |
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This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatic nodule group | Experimental | This group meets eligibility criteria, and undergo contrast-enhanced ultrasound (CEUS) and scheduled gadoxetic acid MRI (gadoxetic acid-enhanced liver MRI; EOB-MRI; Gd-EOB-MRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contrast-enhanced ultrasound | Diagnostic Test | CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of CEUS for diagnosing HCC | accuracy, sensitivity, specificity of CEUS for HCC diagnosis | 3 months after CEUS |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018 | accuracy, sensitivity, specificity of MRI using LI-RADS v2018 for HCC diagnosis | 3 months after MRI |
| Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018 |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| EOB-MRI | Diagnostic Test | EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution. |
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accuracy, sensitivity, specificity of MRI using KLCSG-NCC guideline v2018 for HCC diagnosis |
| 3 months after MRI |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |