Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

N/A Completed NCT04800094

Condition	Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Phase	N/A
Sponsor	Philips Clinical & Medical Affairs Global
Status	Completed
Enrollment	30 participants
Interventions	Investigational Liver Fat Quantification Software
Start date	Mar 2, 2021
Completion date	Dec 13, 2022
Results posted	Jan 27, 2026

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 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

Open in BENITIONS View on ClinicalTrials.gov

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This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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