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Completed

NCT Number: NCT04180631

Quantitative US for Hepatic Steatosis

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.

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Key information

Conditions

Hepatic Steatosis Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative ultrasound imaging parameter (QUS)

Diagnostic Test

Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis

Primary outcomes

  1. 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

Secondary outcomes

  1. Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver

    Time frame: 3 months

    reference standard: MR fat fraction

  2. 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. Intra-observer agreement of quantitative ultrasound imaging parameter

    Time frame: same 1 day

    intraclass correlation coefficient (ICC)

  4. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Samsung Medison

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2019
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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