Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

Study Overview
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Brief Summary
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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.

Official Title
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The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease

Conditions
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Fatty Liver, Fatty Liver, Nonalcoholic

Intervention / Treatment
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* Diagnostic Test: Quantitative US (Samsung Medison, RS85A)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: quantitative ultrasound imaging parameters<br>quantitative ultrasound imaging parameters tissue attenuation imaging (TAI) parameter tissue scatter-distribution imaging (TSI) parameter Hepatorenal index (semi-auto, EzHRI) | Diagnostic Test: Quantitative US (Samsung Medison, RS85A)<br>* In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |