Non-Alcoholic Fatty Liver DiseaseNCT04800094

Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

A study testing Investigational Liver Fat Quantification Software in people with Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis, run by Philips Clinical & Medical Affairs Global at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 5 to 21 years
Conditions the study is for: Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
What is being tested?: Investigational Liver Fat Quantification Software
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2021to 13 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Phoenix Children's Hospital
Phoenix, Arizona, 85016

Other trials in United States

About this 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

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
Being tested: Investigational Liver Fat Quantification Software
Keywords: Liver Fat Quantification, Ultrasound, Liver Disease, Digestive System Disease
Medical subject headings: Non-alcoholic Fatty Liver Disease, Liver Diseases, Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational Liver Fat Quantification SoftwareDevice
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 groups in NCT04800094
Study group	Role	What they receive
Investigational Ultrasound Imaging for Liver Fat Quantification	Experimental	Not described Receives: Device: Investigational Liver Fat Quantification Software

What is being measured

The primary outcome is the main question the study is designed to answer.

Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Hepatorenal Index (HRI) Ultrasound Biomarker for Liver Fat.
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. The difference between the two operators was calculated at the subject level by averaging multiple measurements. To assess the correlation between measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. A higher HRI value indicates greater liver fat accumulation, which reflects a worse outcome, while a lower HRI suggests less hepatic fat and a better outcome.
Measured: Intra-procedural (1 day)
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat.
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record.
Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance. A higher attenuation value indicates worse liver condition, while a lower attenuation value suggests better liver status.
Measured: Intra-procedural (1 day)
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarkers for Liver Fat.
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. This measured the MRI PDFF fat fraction used as the standard to evaluate the Tissue stiffness (kPa) measurements.
Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance.
Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.
Measured: Intra-procedural (1 day)

Secondary outcomes (6)

To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)"
To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition. The difference between the two operators was calculated at the subject level by averaging multiple measurements. A higher HRI value indicates greater liver fat accumulation, which reflects a worse outcome, while a lower HRI suggests less hepatic fat and a better outcome.
Measured: Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)"
To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations
Measured: Intra-procedural (1 day)
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)
To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition.
The difference between the two operators was calculated at the subject level by averaging multiple measurements.
Measured: Intra-procedural (1 day)
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa)
To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition.
The difference between the two operators was calculated at the subject level by averaging multiple measurements.
Measured: Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa)
To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations
Measured: Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)
To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations
Measured: Intra-procedural (1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202113 Dec 2022

First posted16 Mar 2021
Study start2 Mar 2021
Primary completion13 Dec 2022
Study completion13 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04800094
Sponsor's protocol ID: US-GIS-10983
Status last verified: Sep 2024
First submitted: 10 Mar 2021
Last updated: 27 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04800094
Acronym / sponsor ID: US-GIS-10983
Conditions: Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Keywords: Liver Fat Quantification, Ultrasound, Liver Disease, Digestive System Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
Study start: 2 Mar 2021 (actual)
Primary completion: 13 Dec 2022 (actual)
Study completion: 13 Dec 2022 (actual)
First posted: 16 Mar 2021 (actual)
Results: Posted 27 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Investigational Ultrasound Imaging for Liver Fat Quantification	Experimental	Device: Investigational Liver Fat Quantification Software

Who may qualify

Ages: 5 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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.
Overweight or obese (BMI-for-age ≥ 85th percentile).
Diagnosed with Type 2 diabetes per standard clinical guidelines.
Diagnosed with hypercholesterolemia per standard clinical guidelines.

Key exclusion criteria (14 listed)

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:

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
Investigational Liver Fat Quantification SoftwareAll 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.	Device	Investigational Ultrasound Imaging for Liver Fat Quantification

Primary outcome

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)
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. The difference between the two operators was calculated at the subject level by averaging multiple measurements. To assess the correlation between measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. A higher HRI value indicates greater liver fat accumulation, which reflects a worse outcome, while a lower HRI suggests less hepatic fat and a better outcome.
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat.
Time frame: Intra-procedural (1 day)
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance. A higher attenuation value indicates worse liver condition, while a lower attenuation value suggests better liver status.
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarkers for Liver Fat.
Time frame: Intra-procedural (1 day)
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. This measured the MRI PDFF fat fraction used as the standard to evaluate the Tissue stiffness (kPa) measurements. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.

6 secondary outcomes

To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)"
Time frame: Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)"
Time frame: Intra-procedural (1 day)
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)
Time frame: Intra-procedural (1 day)
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa)
Time frame: Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa)
Time frame: Intra-procedural (1 day)
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)
Time frame: Intra-procedural (1 day)

Results and safety

Results posted to the registry on 27 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Ultrasound Imaging for Liver Fat Quantification	30	30

Primary outcome: 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). Mean (Standard Deviation). Unit: Hepatorenal Index

Measure	Hepatorenal Index: Investigational Ultrasound Imaging for Liver Fat Quantification n = 30
Value	1.7 (0.7)

Hepatorenal Index: Investigational Ultrasound Imaging for Liver Fat Quantification: Pearson correlation coefficient: 0.4459
Hepatorenal Index: Investigational Ultrasound Imaging for Liver Fat Quantification: Pearson correlation coefficient: 0.5431
Hepatorenal Index: Investigational Ultrasound Imaging for Liver Fat Quantification: Mixed Model: 0.4871

Population analysed: Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 60 non missing scans reviewed for this study. The primary outcome measure, the Hepatorenal Index, was calculated based on these scans. The hepatorenal index measurement from each ultrasound scan was reviewed.

Primary outcome: Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat.

Time frame: Intra-procedural (1 day). Mean (Standard Deviation). Unit: dB/CM/MHz

Measure	Acoustic Attenuation: Investigational Ultrasound Imaging for Liver Fat Quantification n = 30
Value	0.6 (0.1)

Acoustic Attenuation: Investigational Ultrasound Imaging for Liver Fat Quantification: Pearson correlation coefficient: 0.1742
Acoustic Attenuation: Investigational Ultrasound Imaging for Liver Fat Quantification: Pearson correlation coefficient: 0.1770
Acoustic Attenuation: Investigational Ultrasound Imaging for Liver Fat Quantification: Correlation estimated from a mixed model: 0.1756

Population analysed: Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 60 scans reviewed for this study. The primary outcome measure, the Acoustic Attenuation (dB/cm/MHZ), was evaluated based on these scans. The acoustic attenuation from each ultrasound was reviewed.

Primary outcome: Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarkers for Liver Fat.

Time frame: Intra-procedural (1 day). Mean (Standard Deviation). Unit: kPa

Measure	Tissue Stiffness: Investigational Ultrasound Imaging for Liver Fat Quantification n = 30
Value	6.6 (1.6)

Tissue Stiffness: Investigational Ultrasound Imaging for Liver Fat Quantification: Pearson correlation coefficient: 0.0810
Tissue Stiffness: Investigational Ultrasound Imaging for Liver Fat Quantification: Pearson correlation coefficient: 0.0902
Tissue Stiffness: Investigational Ultrasound Imaging for Liver Fat Quantification: Correlation estimated from a mixed model: 0.0841

Population analysed: Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 60 scans reviewed for this study. Two scans were not usable and were excluded from the analysis. So, a total of 58 scans were included for this analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 8 weeks from enrollment to completion of all study-related procedures. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Ultrasound Imaging for Liver Fat Quantification	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Smita S Bailey, MD principal investigator

Phoenix Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 27 Jan 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04800094.

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 27 Jan 2026.