Computed Tomography
Conditions
Keywords
Precise Image, CT5300, Incisive CT
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. 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.
Interventions
None listed
Sponsors
Philips Clinical & Medical Affairs Global
Philips Healthcare (Suzhou) Co., Ltd.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to 18 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale | 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. |
Outcome results
None listed