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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04462562
Other study ID # SNUH 2002-020-1099
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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