Precise Image for Pediatrics

NCT07317466 | Not Yet Recruiting

• 1 other identifier: SEF-2025-301222
• Study Type: observational
• Target: 168
• Locations: 0 countries
• Sites: N/A

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:

1. 1.To evaluate the image quality and diagnostic confidence of Precise Image compared to the standard-of-care reference (iDose4) for:
2. 2.Head and body CT images of pediatric patients (from 18 months up to and including 18 years of age).
3. 3.To demonstrate non-inferiority of Precise Image to iDose4 for the relevant anatomy and resolution groups.

Conditions

Computed Tomography

Keywords

Precise Image; CT5300; Incisive CT

Outcome Measures

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.

  Reading session at 4 months

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatrics

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Philips Healthcare (Suzhou) Co., Ltd.: collaborator

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: January 5, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08