NCT06095479

Ultrasound Liver Fat Quantification on Pediatric Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Philips (China) Investment CO., LTD · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study.

Detailed description

This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study. To assess the correlation between the quantitative ultrasound biomarkers, i.e., HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI proton density fat fraction (MRI-PDFF) on pediatric patients, in order to evaluate the technical feasibility of using HRIQ, AttenQ and ElastQ to quantify liver fat content for pediatric patients.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DEVICE	2D ultrasound scan and MRI examination	All subjects will undergo a 2D ultrasound scan and MRI examination.

Timeline

• Start date: 2022-07-29
• Primary completion: 2023-11-18
• Completion: 2024-12-30
• First posted: 2023-10-23
• Last updated: 2025-09-16

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study