Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease

Seoul National University Hospital1 site in 1 country124 target enrollmentMarch 5, 2019

ConditionsHepatic Steatosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatic Steatosis
Sponsor: Seoul National University Hospital
Enrollment: 124
Locations: 1
Primary Endpoint: Correlation between quantitative US imaging parameter (QUS) and MR fat fraction
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 5, 2019

End Date

January 19, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jeong Min Lee

Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Correlation between quantitative US imaging parameter (QUS) and MR fat fraction

Time Frame: 3 months

reference standard: MR spectroscopy or MRI-proton density fat fraction value

Secondary Outcomes

Correlation between S-shearwave elastography and MR elastography(3 months)
Development and validation of deep learning model for prediction of hepatic steatosis(1 month)
Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver(3 months)
Intra-observer agreement of quantitative ultrasound imaging parameter(same 1 day)