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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04180631
Other study ID # SNUH-1808-155-967
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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