Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

Philips Clinical & Medical Affairs Global30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Non-Alcoholic Fatty Liver Disease Non-Alcoholic Steatohepatitis

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.