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NCT04800094 · ClinicalTrials.gov registry record · NA

Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

A NA study, sponsored by Philips Clinical & Medical Affairs Global.

Completed
Registry status
NA
Development phase
30
Enrollment target

NCT04800094: Completed NA study, sponsored by Philips Clinical & Medical Affairs Global.

NCT04800094 is a NA study that has completed, run by Philips Clinical & Medical Affairs Global. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04800094, a NA study, has completed, sponsored by Philips Clinical & Medical Affairs Global.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target

Study 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.

Primary Outcome

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 o

Interventions

  • DEVICE Investigational Liver Fat Quantification Software

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-03-02
Est. Completion 2022-12-13
Phase NA

What the finished NCT04800094 record still lists

NCT04800094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Investigational Liver Fat Quantification Software is the first listed.

NCT04800094 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04800094 about?

NCT04800094 is a clinical study titled "Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study". 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 clini...

What is the current status of trial NCT04800094?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2021-03-02. Estimated completion is 2022-12-13.

What interventions are being tested in trial NCT04800094?

The interventions under investigation include: Investigational Liver Fat Quantification Software (DEVICE).

Who is sponsoring clinical trial NCT04800094?

This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 45 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04800094's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04800094, the US trial registry maintained by the National Library of Medicine. NCT04800094 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.