Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

不适用已完成 NCT04800094

适应症	Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
分期	不适用
申办方	Philips Clinical & Medical Affairs Global
状态	已完成
受试者人数	30 人
干预（药物）	Investigational Liver Fat Quantification Software
开始日期	2021年3月2日
完成日期	2022年12月13日
结果公布日	2026年1月27日

摘要

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

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

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

Pearson correlation coefficient	0.0810

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

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全部试验

本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。

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