Quantitative US for Hepatic Steatosis

Study Overview
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Brief Summary
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The purpose of this study is to investigate the diagnostic performance of quantitative ultrasound imaging parameter for the assessment of hepatic steatosis 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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Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease

Conditions
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Hepatic Steatosis

Intervention / Treatment
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* Diagnostic Test: Quantitative ultrasound imaging parameter (QUS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with clinically suspected non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or living-donor candidates for liver transplantation, or volunteers Signed informed consent Exclusion Criteria: chronic liver disease patients (serum HBsAg positive or anti-hepatitis C virus (HCV), histologic confirmation) chronic alcoholics serum alanine transaminase (ALT)>5 times the upper limit of normal within 3 months previous liver surgery acute hepatitis or bile duct obstruction

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 parameter<br>Quantitative ultrasound imaging parameter (QUS) | Diagnostic Test: Quantitative ultrasound imaging parameter (QUS)<br>* Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between quantitative US imaging parameter (QUS) and MR fat fraction | reference standard: MR spectroscopy or MRI-proton density fat fraction value | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver | reference standard: MR fat fraction | 3 months | 
| Correlation between S-shearwave elastography and MR elastography | Reference standard: liver stiffness at MR elastography, using Pearson's correlation analysis or Spearman rank correlation analysis | 3 months | 
| Intra-observer agreement of quantitative ultrasound imaging parameter | intraclass correlation coefficient (ICC) | same 1 day | 
| Development and validation of deep learning model for prediction of hepatic steatosis | ROC analysis and C-index for deep learning model for prediction of hepatic steatosis | 1 month |