Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Samsung Medison | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quantitative ultrasound imaging parameters | Experimental | quantitative ultrasound imaging parameters
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative US (Samsung Medison, RS85A) | Diagnostic Test | In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent) | Reference standard: MRI-proton density fat fraction or MR spectroscopy value (5 percent) - ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >5 percent patients | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent) | Reference standard: MRI-PDFF or MR spectroscopy value (10 percent, 15 percent, 15 percent, 20 percent, 25 percent) - ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >10, >20 percent patients | 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36594835 | Derived | Jeon SK, Lee JM, Joo I, Yoon JH, Lee G. Two-dimensional Convolutional Neural Network Using Quantitative US for Noninvasive Assessment of Hepatic Steatosis in NAFLD. Radiology. 2023 Apr;307(1):e221510. doi: 10.1148/radiol.221510. Epub 2023 Jan 3. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Correlation of QUS parameters and MR fat fraction | reference standard: MRI-PDFF or MR spectroscopy value (percent) - spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent) | 1 month |
| Intra-observer agreement of quantitative US parameters | Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value) | 1 day |
| Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction | pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction | 1 month |
| Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent) | Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 20 percent) | 1 month |
| Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent) | Reference standard: MRI-proton density fat fraction (5 percent) | 1 month |