---
title: Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
nct_id: NCT04800094
overall_status: COMPLETED
phase: NA
sponsor: Philips Clinical & Medical Affairs Global
study_type: INTERVENTIONAL
primary_condition: Non-Alcoholic Fatty Liver Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04800094.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04800094"
ct_last_update_post_date: 2026-01-27
last_seen_at: "2026-05-12T06:22:10.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04800094](https://clinicaltrials.gov/study/NCT04800094)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Philips Clinical & Medical Affairs Global
- **Conditions:** Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
- **Start Date:** 2021-03-02
- **Completion Date:** 2022-12-13
- **CT.gov Last Update:** 2026-01-27

## 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.

## Eligibility

- **Minimum age:** 5 Years
- **Maximum age:** 21 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Investigational Ultrasound Imaging for Liver Fat Quantification** (EXPERIMENTAL)

## 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.

## Primary Outcomes

- **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.

## 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))_

## Locations (1)

- Phoenix Children's Hospital, Phoenix, Arizona, United States

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.phoenix children's hospital|phoenix|arizona|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04800094*  
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