Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

NCT04800094 | Completed Results FDA Device

• 1 other identifier: US-GIS-10983
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease

Keywords

Liver Fat Quantification; Ultrasound; Liver Disease; Digestive System Disease

Outcome Measures

Primary Outcomes (3)

• Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Hepatorenal Index (HRI) Ultrasound Biomarker for Liver Fat.

  For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. The difference between the two operators was calculated at the subject level by averaging multiple measurements. To assess the correlation between measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. A higher HRI value indicates greater liver fat accumulation, which reflects a worse outcome, while a lower HRI suggests less hepatic fat and a better outcome.

  Intra-procedural (1 day)

• Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat.

  For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance. A higher attenuation value indicates worse liver condition, while a lower attenuation value suggests better liver status.

  Intra-procedural (1 day)

• Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarkers for Liver Fat.

  For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. This measured the MRI PDFF fat fraction used as the standard to evaluate the Tissue stiffness (kPa) measurements. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.

  Intra-procedural (1 day)

Secondary Outcomes (6)

• To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)"

  Intra-procedural (1 day)

• To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)"

  Intra-procedural (1 day)

• To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)

  Intra-procedural (1 day)

• To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa)

  Intra-procedural (1 day)

• To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa)

  Intra-procedural (1 day)

Study Arms (1)

Investigational Ultrasound Imaging for Liver Fat Quantification

EXPERIMENTAL

Device: Investigational Liver Fat Quantification Software

Interventions

Investigational Liver Fat Quantification Software DEVICE

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.

Investigational Ultrasound Imaging for Liver Fat Quantification

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• FU-based adjuvant chemotherapy
• Apo-B inhibitors (mipomersen, lomitapide)
• Tetracycline exceeding 2 g/day
• Acetylsalicylic acid exceeding 150 mg/kg

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Fatty Liver

Results Point of Contact

• Title: Rob Johnson; Clinical Study Manager
• Organization: Philips Ultrasound LLC

rob.johnson_1@philips.com

4252757276

Study Officials

• Smita S Bailey, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: March 2, 2021
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2024-09

Locations

US (1)