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Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC.
The investigators would compare the diagnostic performance for HCC at high-risk individuals between both USG contrast agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEUS with perfluorobutane and sulfur hexafluoride | Experimental | Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contrast enhanced ultrasound | Diagnostic Test | contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy for HCC: non-inferiority test | The per-lesion diagnostic accuracy for HCC of CEUS with perfluorobutane and sulfur hexafluoride using the same diagnostic criteria (arterial phase hyperenehancement with mild and late (≥ 60 sec) washout). | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of perfulorobutane enhanced USG using different definition of washout | Per-lesion sensitivity and specificity for diagnosing HCC using different time windows for assessing washout in PFB-US | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Role of perfluorobutane enhanced USG in EASL diagnostic algorithm of HCC | The number of perfluorobutane enhanced USG diagnosed HCC that were missed by prior gadoxetic-acid MRI to simulate diagnostic algorithm for HCC and reveal the role of PFB-US as a second-line diagnostic modality | up to 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, Dr. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 03038 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36196767 | Derived | Kang HJ, Lee JM, Yoon JH, Yoo J, Choi Y, Joo I, Han JK. Sonazoid versus SonoVue(R) for Diagnosing Hepatocellular Carcinoma Using Contrast-Enhanced Ultrasound in At-Risk Individuals: A Prospective, Single-Center, Intraindividual, Noninferiority Study. Korean J Radiol. 2022 Nov;23(11):1067-1077. doi: 10.3348/kjr.2022.0388. Epub 2022 Sep 30. |
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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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Study participants underwent contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride. The diagnostic performance will be compared intra-individually.
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| Dynamic CT | Diagnostic Test | Participants underwent dynamic CT for hepatic lesion |
|
| Liver MRI | Diagnostic Test | Participants underwent liver MRI for hepatic lesion |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |