Precise Image for Pediatrics

December 18, 2025 updated by: Philips Clinical & Medical Affairs Global

Clinical Study for Precise Image for Pediatrics for Incisive CT and CT 5300 Systems

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pediatrics

Description

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:

  • 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).
  • 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 are not completed due to technical difficulties.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale
Time Frame: Reading session at 4 months
The image quality and diagnostic confidence of Precise Image reconstructions is 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.
Reading session at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

Philips Healthcare (Suzhou) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Precise Image for Pediatrics

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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