Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

Non-Alcoholic Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800094
• Other study ID #: US-GIS-10983
• Status: Completed
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: December 13, 2022

Study information

• Verified date: January 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis

Intervention

Device:
• Investigational Liver Fat Quantification Software
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.

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.	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	Inter-operator variability in measurements of ultrasound biomarkers for liver fat	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	Intra-procedural (1 day)
Secondary	Ultrasound biomarker measurement failure rate	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.	Intra-procedural (1 day)