Clinical trial NCT04800094: Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
Official title: Pilot Study of On-Cart Liver Fat Quantification (LFQ) Feature to Assess Correlation With Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) Results in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Non-Alcoholic Steatohepatitis
Keywords: Liver Fat Quantification
Ultrasound
Liver Disease
Digestive System Disease
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.
timeFrame: Intra-procedural (1 day)
Secondary outcomes:
measure: Inter-operator variability in measurements of ultrasound biomarkers for liver fat
timeFrame: Intra-procedural (1 day)
measure: Ultrasound biomarker measurement failure rate
timeFrame: Intra-procedural (1 day)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Smita S Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: