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Not yet recruitingNCT07317466Updated Aug 25, 2026

Precise Image for Pediatrics

An observational study in Computed Tomography, sponsored by Philips Clinical & Medical Affairs Global. Not yet recruiting. Open to participants aged 18 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Philips Clinical & Medical Affairs Global (part of Philips) · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
168
Ages
18 Months to 18 Years
Sex
All
01

Study summary

The purpose of this clinical study is to evaluate the performance of the Precise Image reconstruction algorithm in pediatric patients (specifically, head and body CT imaging of patients from 18 months up to and including 18 years of age). Clinical data generated from this study is intended to support a proposed expansion of the intended population of Precise Image.

The study has two objectives:

  1. To evaluate the image quality and diagnostic confidence of Precise Image compared to the standard-of-care reference (iDose4) for:

    • Head and body CT images of pediatric patients (from 18 months up to and including 18 years of age).
  2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant anatomy and resolution groups.
Read the detailed description

This is a retrospective, observational, multi-site, controlled, blinded, non-inferiority clinical investigation.

Precise Image is a reconstruction mode using a trained deep learning neural network to generate images with reduced noise and improved low contrast detectability at lower doses compared with standard FBP (filter back projection) reconstruction.

Pediatric subjects (from 18 months up to and including 18 years of age) scanned by the FDA-cleared Philips Incisive CT (K212441) or CT 5300 (K232491) systems.

The study will include reconstructed images of 168 CT scans in total. For each of the anatomies and resolutions, 42 scans will be used.

02

Conditions studied

  • Computed Tomography

Keywords

  • Precise Image
  • CT5300
  • Incisive CT
03

In context

Lead sponsor

Philips Clinical & Medical Affairs Global is the lead sponsor of 85 studies on the registry; 25 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.

Browse Philips Clinical & Medical Affairs Global studies →All Philips studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pediatrics

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects scanned by FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable anatomies.
  • Subject age: From 18 months up to and including 18 years of age.

Exclusion criteria

Exclusion Criteria:

  • Subject age: Below 18 months and above 18 years of age.
  • Scans that were acquired using generic 'Head' and 'Body' scan types (as Precise Image does not support generic 'Head' and 'Body' scan types).
  • Head scans (brain and sinus/facial/orbits) acquired with a kilovoltage peak (kVp) outside the range of 100-120 kVp (as Precise Image does not support kVp settings outside this range for these clinical scan types).
  • Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp).
  • Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
  • Scans that failed internal technical checks (e.g., corrupt files, failure to reconstruct).
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
168 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale

    The image quality and diagnostic acceptability of Precise Image reconstructions are non-inferior to iDose4 reconstructions for head and body CT images of pediatric patients (from 18 months up to and including 18 years of age). Measurement will be done via 5-point Likert Scale for Image Quality where 5 is excellent and 1 is poor image quality.

    Time frame: Reading session at 4 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Apr 2027, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2025
First posted
Jan 5, 2026
StartEst.
Oct 31, 2026
Primary completionEst.
Apr 30, 2027
CompletionEst.
Jul 1, 2027
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07317466
Lead sponsor
Philips Clinical & Medical Affairs Global
Collaborators
Philips Healthcare (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Jan 5, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Aug 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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