Quantitative US for Hepatic Steatosis
Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2019
CompletedStudy Start
First participant enrolled
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
November 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2020
CompletedAugust 19, 2021
August 1, 2021
11 months
January 8, 2019
August 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver
3 months
Correlation between S-shearwave elastography and MR elastography
3 months
Intra-observer agreement of quantitative ultrasound imaging parameter
same 1 day
Development and validation of deep learning model for prediction of hepatic steatosis
1 month
Study Arms (1)
Quantitative ultrasound imaging parameter
EXPERIMENTALQuantitative ultrasound imaging parameter (QUS)
Interventions
Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Samsung Medisoncollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Jeon SK, Lee JM, Joo I, Yoon JH, Lee G. Two-dimensional Convolutional Neural Network Using Quantitative US for Noninvasive Assessment of Hepatic Steatosis in NAFLD. Radiology. 2023 Apr;307(1):e221510. doi: 10.1148/radiol.221510. Epub 2023 Jan 3.
PMID: 36594835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeon Min Lee
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 8, 2019
First Posted
November 27, 2019
Study Start
March 5, 2019
Primary Completion
January 19, 2020
Study Completion
January 19, 2020
Last Updated
August 19, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share