Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

NCT ID: NCT04800094

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2022-12-13

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Investigational Ultrasound Imaging for Liver Fat Quantification

Group Type: EXPERIMENTAL

Investigational Liver Fat Quantification Software

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Smita S Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Children's Hospital

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

US-GIS-10983

Identifier Type: -

Identifier Source: org_study_id