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
Verified date | March 2022 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Samsung Medison |
Korea, Republic of,
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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