The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease

Seoul National University Hospital1 site in 1 country173 target enrollmentJuly 3, 2020

ConditionsFatty Liver Fatty Liver, Nonalcoholic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fatty Liver
Sponsor: Seoul National University Hospital
Enrollment: 173
Locations: 1
Primary Endpoint: Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values 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.

Registry

clinicaltrials.gov

Start Date

July 3, 2020

End Date

June 29, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jeong Min Lee

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•patients with known NAFLD or suspected of having NAFLD
•Patients who are scheduled hepatectomy for living donor liver donation
•aged ≥ 18 years who are willing and able to complete all procedures

Exclusion Criteria

•excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)
•clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders
•use of steatogenic or hepatotoxic medication
•evidence of decompensated liver disease
•history of liver surgery
•contraindication to MRI
•any other condition believed by investigator to affect a patients' compliance, or completion of the study

Outcomes

Primary Outcomes

Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)

Time Frame: 1 month

Reference standard: MRI-proton density fat fraction or MR spectroscopy value (5 percent) - ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF \>5 percent patients

Secondary Outcomes

Correlation of QUS parameters and MR fat fraction(1 month)
Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction(1 month)
Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)(1 month)
Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)(1 month)
Intra-observer agreement of quantitative US parameters(1 day)
Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent)(1 month)