BENITIONSClinical Trial Intelligence

Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

N/A Completed NCT04657523

ConditionNon-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
PhaseN/A
SponsorPhilips Clinical & Medical Affairs Global
StatusCompleted
Enrollment60 participants
InterventionsInvestigational Liver Fat Quantification Software
Start dateOct 30, 2020
Completion dateJan 18, 2023
Results postedJan 23, 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 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 Quantification1.6 ± 0.7 Hepatorenal Index
Pearson correlation coefficient0.5749

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 Quantification1.0 ± 0.7 dB/cm/MHZ
Pearson correlation coefficient0.6824

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 Quantification5.9 ± 1.8 kPa
Pearson correlation coefficient-0.0539

Open in BENITIONS View on ClinicalTrials.gov

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