Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

Not Applicable

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis
• Interventions: Device: Investigational Liver Fat Quantification Software

• Registration Number: NCT04800094
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-02
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-16
• Status Verified: 2022-01
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Subjects at least 5 years old up through and including 21 years old who are able to provide informed consent to participate or have a legal representative/parent/legal guardian who is able to provide informed consent for the subject to participate.
• Subjects 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 2 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.

Exclusion Criteria

• History of moderate/heavy/binge alcohol consumption exceeding NIAAA guidelines.

• Evidence of hepatotoxicity or cirrhosis in the clinical judgment of the investigator.

• History of chronic liver disease other than NAFLD (e.g., viral, cholestatic, or autoimmune).

• Use of drugs associated with hepatic steatosis:

  • Amiodarone
  • Methotrexate
  • 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
  • Acetylsalicylic acid exceeding 150 mg/kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Ultrasound Imaging for Liver Fat Quantification	Investigational Liver Fat Quantification Software	-

Primary Outcome Measures

Name	Time	Method
Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.	Intra-procedural (1 day)	Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.

Secondary Outcome Measures

Name	Time	Method
Ultrasound biomarker measurement failure rate	Intra-procedural (1 day)	The ultrasound biomarker measurement failure rate will be assessed by measuring the percentage of subjects in whom measurements cannot be made due to technical limitations.
Inter-operator variability in measurements of ultrasound biomarkers for liver fat	Intra-procedural (1 day)	Inter-operator variability will be assessed by comparing the ultrasound biomarkers measured from each subject by two different operators who have received standardized training. Following biomarkers will be measured: * Hepatorenal Index; * Acoustic attenuation

Trial Locations

Locations (1)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States