Hepatic Steatosis Clinical Trial
Official title:
Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease
Verified date | August 2021 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 124 |
Est. completion date | January 19, 2020 |
Est. primary completion date | January 19, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Samsung Medison |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver | reference standard: MR fat fraction | 3 months | |
Secondary | 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 | |
Secondary | Intra-observer agreement of quantitative ultrasound imaging parameter | intraclass correlation coefficient (ICC) | same 1 day | |
Secondary | 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 |
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