Non-Alcoholic Fatty Liver DiseaseNCT06095479
Ultrasound Liver Fat Quantification on Pediatric Patients
A study testing 2D ultrasound scan and MRI examination in people with Non-Alcoholic Fatty Liver Disease, run by Philips (China) Investment CO., LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- 2D ultrasound scan and MRI examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
About this study
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- 2D ultrasound scan and MRI examination
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D ultrasound scan and MRI examinationDevice
All subjects will undergo a 2D ultrasound scan and MRI examination.
| Study group | Role | What they receive |
|---|---|---|
| undergo standard abdominal ultrasound imaging and MRI-PDFF | Experimental | 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). Receives: Device: 2D ultrasound scan and MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 28 months
Secondary outcomes (1)
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.
Measured: up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start29 Jul 2022
- Primary completion18 Nov 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips (China) Investment CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095479
- Sponsor's protocol ID
- ICBE-S-000403
- Status last verified
- May 2025
- First submitted
- 12 Oct 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Liver Fat Quantification on Pediatric Patients
- ClinicalTrials.gov ID
- NCT06095479
- Acronym / sponsor ID
- ICBE-S-000403
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Philips (China) Investment CO., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 18 Nov 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| undergo standard abdominal ultrasound imaging and MRI-PDFF | Experimental | Device: 2D ultrasound scan and MRI examinationStudy-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). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D ultrasound scan and MRI examinationAll subjects will undergo a 2D ultrasound scan and MRI examination. | Device | undergo standard abdominal ultrasound imaging and MRI-PDFF |
Primary outcome
Rate of HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI
Time frame: up to 28 months
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.
1 secondary outcome
The concentration of robustness of the investigational LFQ software in the clinical settings
Time frame: up to 28 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2D ultrasound scan and MRI examination in people with Non-Alcoholic Fatty Liver Disease, run by Philips (China) Investment CO., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI (time frame: up to 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.