Precise Image for Pediatrics | NCT07317466

Studies
Precise Image for Pediatrics

NCT07317466

Sponsor

Philips Clinical & Medical Affairs Global

Status

Not yet recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

168Estimated

Phase

Not provided

Conditions

Computed Tomography

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2026Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Sep 22, 2025

First Submission Date that Met QC Criteria

Dec 18, 2025

First Posted Date

Jan 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2025

Last Update Posted Date

Jan 5, 2026Actual

Name	Class
Philips Healthcare (Suzhou) Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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).
To demonstrate non-inferiority of Precise Image to iDose4 for the relevant anatomy and resolution groups.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

168Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatrics

Sampling Method

Probability Sample