Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

Not Applicable

Completed

• Conditions: Fatty Liver, Nonalcoholic; Fatty Liver
• Interventions: Diagnostic Test: Quantitative US (Samsung Medison, RS85A)

• Registration Number: NCT04462562
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-07-02
• Study Start: 2020-07-03
• Study First Posted: 2020-07-08
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
quantitative ultrasound imaging parameters	Quantitative US (Samsung Medison, RS85A)	quantitative ultrasound imaging parameters * tissue attenuation imaging (TAI) parameter * tissue scatter-distribution imaging (TSI) parameter * Hepatorenal index (semi-auto, EzHRI)

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of