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Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational Liver Fat Quantification Software
Sponsored by
Philips Clinical & Medical Affairs Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Alcoholic Fatty Liver Disease focused on measuring Liver Fat Quantification, Ultrasound, Liver Disease, Digestive System Disease

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Ultrasound Imaging for Liver Fat Quantification

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 10, 2021
Last Updated
January 31, 2023
Sponsor
Philips Clinical & Medical Affairs Global
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1. Study Identification

Unique Protocol Identification Number
NCT04800094
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
December 13, 2022 (Actual)
Study Completion Date
December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Keywords
Liver Fat Quantification, Ultrasound, Liver Disease, Digestive System Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Ultrasound Imaging for Liver Fat Quantification
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Investigational Liver Fat Quantification Software
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.
Description
Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.
Time Frame
Intra-procedural (1 day)
Secondary Outcome Measure Information:
Title
Inter-operator variability in measurements of ultrasound biomarkers for liver fat
Description
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
Time Frame
Intra-procedural (1 day)
Title
Ultrasound biomarker measurement failure rate
Description
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.
Time Frame
Intra-procedural (1 day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smita S Bailey, MD
Organizational Affiliation
Phoenix Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

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