Fatty Liver, Fatty Liver, Nonalcoholic
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTQuantitative US (Samsung Medison, RS85A)
In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed
Sponsors
Samsung Medison
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients with known NAFLD or suspected of having NAFLD * Patients who are scheduled hepatectomy for living donor liver donation * aged ≥ 18 years who are willing and able to complete all procedures
Exclusion criteria
* excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women) * clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders * use of steatogenic or hepatotoxic medication * evidence of decompensated liver disease * history of liver surgery * contraindication to MRI * any other condition believed by investigator to affect a patients' compliance, or completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent) | 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of QUS parameters and MR fat fraction | 1 month | reference standard: MRI-PDFF or MR spectroscopy value (percent) \- spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent) |
| Intra-observer agreement of quantitative US parameters | 1 day | Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value) |
| Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent) | 1 month | 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 |
| 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) | 1 month | Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 20 percent) |
| Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent) | 1 month | Reference standard: MRI-proton density fat fraction (5 percent) |
| Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction | 1 month | pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction |
Countries
South Korea
Outcome results
None listed