Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

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

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.

Study Overview

• Status: Completed
• Conditions: Fatty Liver; Fatty Liver, Nonalcoholic
• Intervention / Treatment: Diagnostic test: Quantitative US (Samsung Medison, RS85A)

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: quantitative ultrasound imaging parameters; quantitative ultrasound imaging parameters; tissue attenuation imaging (TAI) parameter; tissue scatter-distribution imaging (TSI) parameter; Hepatorenal index (semi-auto, EzHRI)	Diagnostic test: Quantitative US (Samsung Medison, RS85A); In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)	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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)	Reference standard: MRI-PDFF or MR spectroscopy value (10 percent, 15 percent, 15 percent, 20 percent, 25 percent) - ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >10, >20 percent patients	1 month
Correlation of QUS parameters and MR fat fraction	reference standard: MRI-PDFF or MR spectroscopy value (percent) - spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent)	1 month
Intra-observer agreement of quantitative US parameters	Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value)	1 day
Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction	pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction	1 month
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)	Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 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)	Reference standard: MRI-proton density fat fraction (5 percent)	1 month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Samsung Medison
• Investigators: Study Director: Jeong Min Lee, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Actual): June 29, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: SNUH 2002-020-1099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No