NCT07317466

Precise Image for Pediatrics

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 168 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Months – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Computed Tomography

Timeline

• Start date: 2026-01-31
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-01-05
• Last updated: 2026-01-05