Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

Seoul National University Hospital173 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

173

Conditions

Fatty Liver Fatty Liver, Nonalcoholic

Interventions

Quantitative US (Samsung Medison, RS85A)DIAGNOSTIC_TEST

In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

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)

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

Time frame: 1 month

Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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