N/A
N=30
Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
Non-Alcoholic Fatty Liver Disease · Non-Alcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT04800094 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Hepatorenal Index (HRI) Ultrasound Biomarker for Liver Fat. — 1.7 Hepatorenal Index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational Liver Fat Quantification Software (Device)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Hepatorenal Index (HRI) Ultrasound Biomarker for Liver Fat. |
1.7 | — |
| PRIMARY Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat. |
0.6 | — |
| PRIMARY Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarkers for Liver Fat. |
6.6 | — |
| SECONDARY To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)" |
-0.5 | — |
| SECONDARY To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)" |
— | — |
| SECONDARY To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) |
-0.01 | — |
| SECONDARY To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa) |
0.7 | — |
| SECONDARY To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa) |
2 | — |
| SECONDARY To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04800094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.