Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT04800094
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Investigational Liver Fat Quantification Software — 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.

Study Details

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.

Key Dates

Start date
Mar 2, 2021
Status verified
Sep 2024
Primary completion
Dec 13, 2022
Completion
Dec 13, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Investigational Ultrasound Imaging for Liver Fat Quantification

Primary Outcome Measure

Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Hepatorenal Index (HRI) Ultrasound Biomarker for Liver Fat. [ Time Frame: Intra-procedural (1 day) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZ

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