Quantitative US for Hepatic Steatosis

August 17, 2021 updated by: Jeong Min Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quantitative ultrasound imaging parameter
Quantitative ultrasound imaging parameter (QUS)
Diagnostic test: Quantitative ultrasound imaging parameter (QUS)
Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver
Time Frame: 3 months
reference standard: MR fat fraction
3 months
Correlation between S-shearwave elastography and MR elastography
Time Frame: 3 months
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
Time Frame: same 1 day
intraclass correlation coefficient (ICC)
same 1 day
Development and validation of deep learning model for prediction of hepatic steatosis
Time Frame: 1 month
ROC analysis and C-index for deep learning model for prediction of hepatic steatosis
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Samsung Medison

Investigators

  • Study Director: Jeon Min Lee, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2019

Primary Completion (Actual)

January 19, 2020

Study Completion (Actual)

January 19, 2020

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-1808-155-967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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