Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462562
• Other study ID #: SNUH 2002-020-1099
• Status: Completed
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: March 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Non-alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Samsung Medison

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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