Ultrasound Liver Fat Quantification on Pediatric Patients

NCT06095479 | Completed FDA Device

• 1 other identifier: ICBE-S-000403
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Rate of HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI

  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.

  up to 28 months

Secondary Outcomes (1)

• The concentration of robustness of the investigational LFQ software in the clinical settings

  up to 28 months

Study Arms (1)

undergo standard abdominal ultrasound imaging and MRI-PDFF

EXPERIMENTAL

Study-related procedures will consist of one investigational exam conducted with the Philips EPIQ Ultrasound System with investigational LFQ software and a standard MRI-PDFF examination. All imaging procedures (investigational LFQ ultrasound exam and MRI-PDFF exam) must be completed within an 8-week window (+ 5 days).

Device: 2D ultrasound scan and MRI examination

Interventions

2D ultrasound scan and MRI examination DEVICE

All subjects will undergo a 2D ultrasound scan and MRI examination.

undergo standard abdominal ultrasound imaging and MRI-PDFF

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects at age of 6-18 years old (≥6 \& \<18) who are able to provide assent to participate and have a parent/legal guardian who is able to provide informed consent for the subject to participate.
• Subject must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination.
• In addition, at least one of the following criteria must also be met:
• Overweight or obese (BMI-for-age ≥ 85th percentile).
• Diagnosed with Type II diabetes per standard clinical guidelines.
• Diagnosed with hypercholesterolemia per standard clinical guidelines.
• Diagnosed with or clinically suspected of having NAFLD/NASH based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing.

You may not qualify if:

• Evidence of hepatotoxicity in the clinical judgment of the investigator.
• History of chronic liver disease (e.g., viral hepatitis, cholestatic hepatitis, or autoimmune liver disease).
• Use of drugs associated with hepatic steatosis1: amiodarone, aethotrexate, nucleoside reverse transcriptase inhibitors (didanosine, stavudine), valproic acid, dexamethasone, tamoxifen, 5-FU-based adjuvant chemotherapy, apo-B inhibitors (mipomersen, lomitapide), tetracycline exceeding 2 g/day and acetylsalicylic acid exceeding 150 mg/kg.
• Note: patients taking tetracycline (≤ 2 g/day), acetylsalicylic acid (≤150 mg/kg) are allowed to be enrolled.
• Subjects with hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition.
• Subjects anticipated or planned to undergo any therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content (e.g., bariatric surgery, chemotherapy).
• History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or MRI image quality or the subject's eligibility to undergo ultrasound or MRI.
• Subjects with unstable clinical status, late stages of a given disease, or unpredictable clinical course of a given disease.
• Subjects with evidence of COVID-19 or with the substantial risk of COVID-19 infection.

Sponsors & Collaborators

• Philips (China) Investment CO., LTD: lead
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200092, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 23, 2023
• Study Start: July 29, 2022
• Primary Completion: November 18, 2023
• Study Completion: December 30, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)