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The purpose of this study is to validate an artificial intelligence (AI)-based algorithm that estimates hepatic steatosis using ultrasound (US) B-mode images in pediatric participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The MRI proton density fat fraction (MRI-PDFF) serves as the reference standard for hepatic fat quantification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver Ultrasound and MRI | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound and MRI | Diagnostic Test | Participants undergo same-day liver imaging including conventional B-mode ultrasound, quantitative ultrasound, and magnetic resonance imaging (MRI). Conventional Ultrasound: B-mode imaging performed on three ultrasound systems (Canon Aplio i800, Philips EPIQ, and Supersonic AIXPLORER) to acquire grayscale liver images for artificial intelligence (AI) analysis. Quantitative Ultrasound: Attenuation imaging (ATI) and shear wave elastography/dispersion measurements performed to assess hepatic fat and stiffness. MRI: Proton density fat fraction (PDFF) measurement used as the reference standard for hepatic steatosis quantification. All imaging is performed on the same day for each participant to ensure temporal consistency across modalities and vendors. |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between AI-Predicted Ultrasound Fat Fraction (AI-USFF) and MRI Proton Density Fat Fraction (MRI-PDFF) | Reference standard: MRI-PDFF (percentage) - intraclass correlation coefficient (ICC) | At time of imaging (single visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between AI-USFF and MRI-PDFF | Reference standard: MRI-PDFF (percentage) - Pearson correlation coefficient (r) | At time of imaging (single visit) |
| Diagnostic Performance of AI-USFF for MRI-Based Hepatic Steatosis Grades |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
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The diagnostic performance of AI-USFF for detecting mild, moderate, and severe hepatic steatosis, as defined by MRI-PDFF thresholds, will be evaluated using area under the receiver operating characteristic curve (AUC).
| At time of imaging (single visit) |
| Inter-Vendor Reproducibility of AI-USFF | Reproducibility of AI-USFF across the three ultrasound systems are assessed using the intraclass correlation coefficient (ICC [2,k]). | At time of imaging (single visit) |