Back to resultsQuantitative US for Hepatic Steatosis
Primary Purpose
Hepatic Steatosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quantitative ultrasound imaging parameter (QUS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatic Steatosis
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quantitative ultrasound imaging parameter
Arm Description
Quantitative ultrasound imaging parameter (QUS)
Outcomes
Primary Outcome Measures
Correlation between quantitative US imaging parameter (QUS) and MR fat fraction
reference standard: MR spectroscopy or MRI-proton density fat fraction value
Secondary Outcome Measures
Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver
reference standard: MR fat fraction
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
Intra-observer agreement of quantitative ultrasound imaging parameter
intraclass correlation coefficient (ICC)
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
Full Information
NCT ID
NCT04180631
First Posted
January 8, 2019
Last Updated
August 17, 2021
Sponsor
Seoul National University Hospital
Collaborators
Samsung Medison
1. Study Identification
Unique Protocol Identification Number
NCT04180631
Brief Title
Quantitative US for Hepatic Steatosis
Official Title
Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
January 19, 2020 (Actual)
Study Completion Date
January 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Samsung Medison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Steatosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quantitative ultrasound imaging parameter
Arm Type
Experimental
Arm Description
Quantitative ultrasound imaging parameter (QUS)
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative ultrasound imaging parameter (QUS)
Intervention Description
Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis
Primary Outcome Measure Information:
Title
Correlation between quantitative US imaging parameter (QUS) and MR fat fraction
Description
reference standard: MR spectroscopy or MRI-proton density fat fraction value
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver
Description
reference standard: MR fat fraction
Time Frame
3 months
Title
Correlation between S-shearwave elastography and MR elastography
Description
Reference standard: liver stiffness at MR elastography, using Pearson's correlation analysis or Spearman rank correlation analysis
Time Frame
3 months
Title
Intra-observer agreement of quantitative ultrasound imaging parameter
Description
intraclass correlation coefficient (ICC)
Time Frame
same 1 day
Title
Development and validation of deep learning model for prediction of hepatic steatosis
Description
ROC analysis and C-index for deep learning model for prediction of hepatic steatosis
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeon Min Lee
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quantitative US for Hepatic Steatosis
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