Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
該当なし
完了
NCT04800094
| 対象疾患 | Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis |
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| 相 | 該当なし |
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| スポンサー | Philips Clinical & Medical Affairs Global |
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| ステータス | 完了 |
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| 参加者数 | 30 名 |
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| 介入(薬剤) | Investigational Liver Fat Quantification Software |
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| 開始日 | 2021年3月2日 |
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| 完了日 | 2022年12月13日 |
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| 結果公開日 | 2026年1月27日 |
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概要
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 one investigational abdominal ultrasound examination 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 of Hepatorenal Index (HRI) Ultrasound Biomarker for Liver Fat.
Intra-procedural (1 day) · Hepatorenal Index
| Hepatorenal Index: Investigational Ultrasound Imaging for Liver Fat Quantification | 1.7 ± 0.7 Hepatorenal Index |
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| Pearson correlation coefficient | 0.4459 |
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
| Acoustic Attenuation: Investigational Ultrasound Imaging for Liver Fat Quantification | 0.6 ± 0.1 dB/CM/MHz |
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| Pearson correlation coefficient | 0.1742 |
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarkers for Liver Fat.
Intra-procedural (1 day) · kPa
| Tissue Stiffness: Investigational Ultrasound Imaging for Liver Fat Quantification | 6.6 ± 1.6 kPa |
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| Pearson correlation coefficient | 0.0810 |
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