NCT04800094

Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

Pilot Study of On-Cart Liver Fat Quantification (LFQ) Feature to Assess Correlation With Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) Results in a Pediatric Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis

Interventions

Type	Name	Description
DEVICE	Investigational Liver Fat Quantification Software	All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.

Timeline

• Start date: 2021-03-02
• Primary completion: 2022-12-13
• Completion: 2022-12-13
• First posted: 2021-03-16
• Last updated: 2026-01-27
• Results posted: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study