Quantitative US for Hepatic Steatosis

Not Applicable

Completed

• Conditions: Hepatic Steatosis
• Interventions: Diagnostic Test: Quantitative ultrasound imaging parameter (QUS)

• Registration Number: NCT04180631
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-08
• Study Start: 2019-03-05
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Primary Completion: 2020-01-19
• Study Completion: 2020-01-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quantitative ultrasound imaging parameter	Quantitative ultrasound imaging parameter (QUS)	Quantitative ultrasound imaging parameter (QUS)

Primary Outcome Measures

Name	Time	Method
Correlation between quantitative US imaging parameter (QUS) and MR fat fraction	3 months	reference standard: MR spectroscopy or MRI-proton density fat fraction value

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of