NCT04462562CompletedNot Applicable
The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
Seoul National University Hospital1 site in 1 country173 target enrollmentStarted: July 3, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 173
- Locations
- 1
- Primary Endpoint
- Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
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)
Time Frame: 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 Outcomes
- Correlation of QUS parameters and MR fat fraction(1 month)
- Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction(1 month)
- 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)
- Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)(1 month)
- Intra-observer agreement of quantitative US parameters(1 day)
- 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)
Investigators
Jeong Min Lee
Professor
Seoul National University Hospital
Study Sites (1)
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