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To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.
The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-sectional image only | No Intervention | Image set which consists of a Cross-sectional image only. | |
| Cross-sectional image with CEUS | Active Comparator | The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contrast enhanced ultrasound | Diagnostic Test | Perflubutane enhanced ultrasound for evaluating hepatic tumor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation | Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI. | 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks. |
| Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS. | Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS. | 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing image characters between two types of ultrasound contrast media | Comparing image characters between two types of ultrasound contrast media | For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo-Jin Kang, M.D. | Contact | 82220723107 | dr.kanghj@gmail.com | |
| Hyun-Hee Lee, B.S. | Contact | 82220723107 | redlion55@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, M.D. | Seoul National University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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For two years after publication.
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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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All participants underwent CEUS. The image reviews based on cross-section images will be performed with or without CEUS results. Two image sets (cross-sectional image with CEUS and without CEUS) will be compared.
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |