Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study
N/A
Completed
NCT04657523
| Condition | Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis |
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| Phase | N/A |
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| Sponsor | Philips Clinical & Medical Affairs Global |
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| Status | Completed |
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| Enrollment | 60 participants |
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| Interventions | Investigational Liver Fat Quantification Software |
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| Start date | Oct 30, 2020 |
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| Completion date | Jan 18, 2023 |
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| Results posted | Jan 23, 2026 |
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Summary
This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD). The primary objective of this clinical study is to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat percentage obtained from MRI Proton Density Fat Fraction (MRI-PDFF) measurements. All subjects enrolled in this study will undergo two investigational abdominal ultrasound examinations using the Philips EPIQ Ultrasound System and one MRI PDFF examination according to the clinical standard of care.
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements Hepatorenal Index (HRI) of Ultrasound Biomarkers for Liver Fat.
Intra-procedural (1 day) · Hepatorenal Index
| Investigational Ultrasound Imaging for Liver Fat Quantification | 1.6 ± 0.7 Hepatorenal Index |
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| Pearson correlation coefficient | 0.5749 |
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat.
Intra-procedural (1 day) · dB/cm/MHZ
| Investigational Ultrasound Imaging for Liver Fat Quantification | 1.0 ± 0.7 dB/cm/MHZ |
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| Pearson correlation coefficient | 0.6824 |
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarker for Liver Fat.
Intra-procedural (1 day) · kPa
| Investigational Ultrasound Imaging for Liver Fat Quantification | 5.9 ± 1.8 kPa |
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| Pearson correlation coefficient | -0.0539 |
Open in BENITIONS
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