BENITIONSClinical Trial Intelligence

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
該当なし
スポンサーPhilips Clinical & Medical Affairs Global
ステータス完了
参加者数30 名
介入(薬剤)Investigational Liver Fat Quantification Software
開始日2021年3月2日
完了日2022年12月13日
結果公開日2026年1月27日

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 Quantification1.7 ± 0.7 Hepatorenal Index
Pearson correlation coefficient0.4459

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 Quantification0.6 ± 0.1 dB/CM/MHz
Pearson correlation coefficient0.1742

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 Quantification6.6 ± 1.6 kPa
Pearson correlation coefficient0.0810

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