Status:
COMPLETED
Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Non-Alcoholic Fatty Liver Disease
Non-Alcoholic Steatohepatitis
Eligibility:
All Genders
5-21 years
Phase:
NA
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 Nonalcoholi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04800094
Start Date
March 2 2021
End Date
December 13 2022
Last Update
February 1 2023
Active Locations (1)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016