Precise Image for Pediatrics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Computed Tomography. Basic parameters: 18 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study for Precise Image for Pediatrics for Incisive CT and CT 5300 Systems
Overview
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.
Primary outcome measures
- Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale [Time frame: Reading session at 4 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07317466 · Precise Image for Pediatrics