Precise Image for Pediatrics

August 21, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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).
  • 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).

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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 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.
Reading session at 4 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philips Clinical & Medical Affairs Global

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEF-2025-301222

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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