Precise Image for Pediatrics

Philips

Status: Not yet enrolling

Conditions: Computed Tomography

Study type: Observational

Funder types: Industry

Identifiers

NCT07317466

Precise Image for Pediatrics

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 months to 18 years old

Volunteers: No Healthy Volunteers

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.