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Ultrasound Liver Fat Quantification on Pediatric Patients

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
2D ultrasound scan and MRI examination
Sponsored by
Philips (China) Investment CO., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects at age of 6-18 years old (≥6 & <18) who are able to provide assent to participate and have a parent/legal guardian who is able to provide informed consent for the subject to participate. Subject 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 II 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: Evidence of hepatotoxicity in the clinical judgment of the investigator. History of chronic liver disease (e.g., viral hepatitis, cholestatic hepatitis, or autoimmune liver disease). Use of drugs associated with hepatic steatosis1: amiodarone, aethotrexate, 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 and acetylsalicylic acid exceeding 150 mg/kg. Note: patients taking tetracycline (≤ 2 g/day), acetylsalicylic acid (≤150 mg/kg) are allowed to be enrolled. Subjects with hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition. Subjects anticipated or planned to undergo any therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content (e.g., bariatric surgery, chemotherapy). History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or MRI image quality or the subject's eligibility to undergo ultrasound or MRI. Subjects with unstable clinical status, late stages of a given disease, or unpredictable clinical course of a given disease. Subjects with evidence of COVID-19 or with the substantial risk of COVID-19 infection.

Sites / Locations

  • Xinhua Hospital affiliated to Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

undergo standard abdominal ultrasound imaging and MRI-PDFF

Arm Description

Study-related procedures will consist of one investigational exam conducted with the Philips EPIQ Ultrasound System with investigational LFQ software and a standard MRI-PDFF examination. All imaging procedures (investigational LFQ ultrasound exam and MRI-PDFF exam) must be completed within an 8-week window (+ 5 days).

Outcomes

Primary Outcome Measures

Rate of HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI
To assess the correlation between the quantitative ultrasound biomarkers, i.e., HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI proton density fat fraction (MRI-PDFF) on pediatric patients, in order to evaluate the technical feasibility of using HRIQ, AttenQ and ElastQ to quantify liver fat content for pediatric patients.

Secondary Outcome Measures

The concentration of robustness of the investigational LFQ software in the clinical settings
To assess the inter-operator variability on the same day and the data acquisition failure rate (i.e., the percentage of the subjects whose image quality is unacceptable due to technical limitations) of these quantitative ultrasound biomarkers, in order to evaluate the robustness of the investigational LFQ software in the clinical settings.

Full Information

First Posted
October 12, 2023
Last Updated
October 18, 2023
Sponsor
Philips (China) Investment CO., LTD
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT06095479
Brief Title
Ultrasound Liver Fat Quantification on Pediatric Patients
Official Title
Ultrasound Liver Fat Quantification on Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips (China) Investment CO., LTD
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study.
Detailed Description
This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study. To assess the correlation between the quantitative ultrasound biomarkers, i.e., HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI proton density fat fraction (MRI-PDFF) on pediatric patients, in order to evaluate the technical feasibility of using HRIQ, AttenQ and ElastQ to quantify liver fat content for pediatric patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
undergo standard abdominal ultrasound imaging and MRI-PDFF
Arm Type
Experimental
Arm Description
Study-related procedures will consist of one investigational exam conducted with the Philips EPIQ Ultrasound System with investigational LFQ software and a standard MRI-PDFF examination. All imaging procedures (investigational LFQ ultrasound exam and MRI-PDFF exam) must be completed within an 8-week window (+ 5 days).
Intervention Type
Device
Intervention Name(s)
2D ultrasound scan and MRI examination
Intervention Description
All subjects will undergo a 2D ultrasound scan and MRI examination.
Primary Outcome Measure Information:
Title
Rate of HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI
Description
To assess the correlation between the quantitative ultrasound biomarkers, i.e., HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI proton density fat fraction (MRI-PDFF) on pediatric patients, in order to evaluate the technical feasibility of using HRIQ, AttenQ and ElastQ to quantify liver fat content for pediatric patients.
Time Frame
up to 28 months
Secondary Outcome Measure Information:
Title
The concentration of robustness of the investigational LFQ software in the clinical settings
Description
To assess the inter-operator variability on the same day and the data acquisition failure rate (i.e., the percentage of the subjects whose image quality is unacceptable due to technical limitations) of these quantitative ultrasound biomarkers, in order to evaluate the robustness of the investigational LFQ software in the clinical settings.
Time Frame
up to 28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects at age of 6-18 years old (≥6 & <18) who are able to provide assent to participate and have a parent/legal guardian who is able to provide informed consent for the subject to participate. Subject 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 II 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: Evidence of hepatotoxicity in the clinical judgment of the investigator. History of chronic liver disease (e.g., viral hepatitis, cholestatic hepatitis, or autoimmune liver disease). Use of drugs associated with hepatic steatosis1: amiodarone, aethotrexate, 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 and acetylsalicylic acid exceeding 150 mg/kg. Note: patients taking tetracycline (≤ 2 g/day), acetylsalicylic acid (≤150 mg/kg) are allowed to be enrolled. Subjects with hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition. Subjects anticipated or planned to undergo any therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content (e.g., bariatric surgery, chemotherapy). History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or MRI image quality or the subject's eligibility to undergo ultrasound or MRI. Subjects with unstable clinical status, late stages of a given disease, or unpredictable clinical course of a given disease. Subjects with evidence of COVID-19 or with the substantial risk of COVID-19 infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaqing Chen
Phone
86-13816135226
Email
Joychen1266@126.com
Facility Information:
Facility Name
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaqing Chen
Phone
86-13816135226
Email
Joychen1266@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound Liver Fat Quantification on Pediatric Patients

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