Quantitative US for Hepatic Steatosis

Hepatic Steatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180631
• Other study ID #: SNUH-1808-155-967
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: January 19, 2020

Study information

• Verified date: August 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis

Intervention

Diagnostic Test:
• Quantitative ultrasound imaging parameter (QUS)
Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Samsung Medison

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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