Quantitative US for Hepatic Steatosis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04180631

Enrollment

124

Registered

2019-11-27

Start date

2019-03-05

Completion date

2020-01-19

Last updated

2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Steatosis

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.

Interventions

DIAGNOSTIC_TESTQuantitative ultrasound imaging parameter (QUS)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver	3 months	reference standard: MR fat fraction
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
Intra-observer agreement of quantitative ultrasound imaging parameter	same 1 day	intraclass correlation coefficient (ICC)
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026