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The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFLD patients who are scheduled for liver biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound application | Diagnostic Test | Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23) | At the time of examination |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between ultrasound parameters and the pathological parameters | At the time of examination | |
| Diagnostic performance of SW speed for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4). | At the time of examination |
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Inclusion Criteria:
Exclusion Criteria:
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Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuminori Moriyasu, MD, PhD | Contact | +81-3-3402-3151 | moriyasy@iuhw.ac.jp | |
| Katsutoshi Sugimoto, MD, PhD | Contact | +81-3-3342-6111 | sugimoto@tokyo-med.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Katsutoshi Sugimoto, MD, PhD | Tokyo Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Recruiting | Los Angeles | California | 90007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39162633 | Derived | Sugimoto K, Moriyasu F, Dioguardi Burgio M, Vilgrain V, Jesper D, Strobel D, Blank V, Karlas T, Grant EG, Kelahan LC, Gabriel H, Choi BI, Nishimura T, Iijima H, Dubinsky TJ, Gao J, Lee DH, Lee JY, Zhao Y, Huang P, Zeng J, Lim A, Xie X, Barr RG, Cantisani V, Ferraioli G, Sakamaki K, Itoi T, Kage M, Yano H. US Markers and Necroinflammation, Steatosis, and Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease: The iLEAD Study. Radiology. 2024 Aug;312(2):e233377. doi: 10.1148/radiol.233377. |
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| Diagnostic performance of Normalized Local Variance for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4) | At the time of examination |
| Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3) | At the time of examination |
| Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3) | At the time of examination |
| Diagnostic performance of Attenuation value for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3) | At the time of examination |
| Diagnostic performance of Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3) | At the time of examination |
| Diagnostic performance of the computer aided algorithm for NASH | At the time of examination |
| Diagnostic performance of MRI-PDFF for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). | At the time of examination |
| Diagnostic performance of CAP for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). | At the time of examination |
| Diagnostic performance of MRE for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4). | At the time of examination |
| Rocky Vista University | Recruiting | Parker | Colorado | 80134 | United States |
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| Northwestern University | Recruiting | Evanston | Illinois | 60208 | United States |
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| The Surgical Hospital at Southwoods | Recruiting | Boardman | Ohio | 44512 | United States |
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| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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| SunYatSen University First Hospital | Recruiting | Guangzhou | China |
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| SunYatSen University Third Hospital | Recruiting | Guangzhou | China |
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| Zhejiang University No. 2 Hospital | Recruiting | Hangzhou | China |
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| University Paris Nord | Not yet recruiting | Paris | France |
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| University of Erlangen | Recruiting | Erlangen | Germany |
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| University of Leipzig | Recruiting | Leipzig | Germany |
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| University of Pavia | Recruiting | Pavia | Italy |
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| Policlinico Umberto I, Univ. La Sapienza | Recruiting | Rome | Italy |
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| Hyogo Medical University | Recruiting | Hyōgo | Japan |
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| Kurume University | Recruiting | Kurume | Japan |
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| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| Charing Cross Hospital / Imperial College London | Recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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