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Quantitative US for Hepatic Steatosis

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04180631
Collaborator
Samsung Medison (Industry)
124
Enrollment
1
Location
1
Arm
10.5
Actual Duration (Months)
11.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Quantitative ultrasound imaging parameter (QUS)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease
Actual Study Start Date :
Mar 5, 2019
Actual Primary Completion Date :
Jan 19, 2020
Actual Study Completion Date :
Jan 19, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Correlation between quantitative US imaging parameter (QUS) and MR fat fraction [3 months]

    reference standard: MR spectroscopy or MRI-proton density fat fraction value

Secondary Outcome Measures

  1. Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver [3 months]

    reference standard: MR fat fraction

  2. Correlation between S-shearwave elastography and MR elastography [3 months]

    Reference standard: liver stiffness at MR elastography, using Pearson's correlation analysis or Spearman rank correlation analysis

  3. Intra-observer agreement of quantitative ultrasound imaging parameter [same 1 day]

    intraclass correlation coefficient (ICC)

  4. Development and validation of deep learning model for prediction of hepatic steatosis [1 month]

    ROC analysis and C-index for deep learning model for prediction of hepatic steatosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital
  • Samsung Medison

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04180631
Other Study ID Numbers:
  • SNUH-1808-155-967
First Posted:
Nov 27, 2019
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fatty Liver

Study Results

No Results Posted as of Aug 19, 2021