Body, Cardiac, Head
Conditions
Keywords
CT, Tomography, Image Quality, Noise reduction
Brief summary
The goal of the study is to evaluate the Image Quality (IQ), and diagnostic confidence of Spectral Precise Image for CT 7700 Scanner as compared with iDose4 as a standard-of-care reference.
Detailed description
Spectral Precise Image is a reconstruction technique where the system uses a trained deep learning neural network to produce an image that reduces noise while improving low contrast detectability and maintaining the appearance of traditional filtered back projection (FBP) images. Spectral Precise Image in Spectral CT 7700 system supports both conventional and spectral reconstructions. The study will use raw data of subjects that are over the age of 22 years and scanned by Philips Spectral CT. Study raw data, following anonymization, will be transferred to Philips for reconstructions, both conventional and spectral images will be reconstructed with iDose4 and with Spectral Precise Image at 100% dose.
Interventions
DEVICEPaired reading analysis
Paired side be side evaluation Each reader will assess- Image Quality (IQ) & Diagnostic Confidence Ratings will be recorded using a 5-point Likert scale
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Subjects scanned by Spectral CT (K203020) according to the department standard of care clinical protocols. * Subjects age \> twenty-two (22) years
Exclusion criteria
* • Scans that the site radiologists have deemed as non-diagnostic image quality in the standard practice (e.g. patient movement) * Scans that are not completed due to technical difficulties
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images | 1 day | Primary Endpoint (Co-Primary endpoints): 1\. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to) iDose4 for conventional images. |
| Image Quality (IQ) of Spectral Precise Image reconstructions non-inferior to iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head). | 1 day | Primary Endpoint (Co-Primary endpoints): 2. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images | 1 day | 1\. To evaluate the difference in Image Quality (IQ) and diagnostic confidence between Spectral Precise Image reconstructions for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head) and iDose4 for conventional images. |
| Evaluation of the success rate for Spectral Precise Image reconstruction | 1 day | 2\. To evaluate the success rate (%) for Spectral Precise Image reconstructions |
| Evaluation of the interobserver agreement level for the Co-Primary endpoints | 1 day | 3\. The interobserver agreement level for the Co-Primary endpoints is more than 0.8. |
| Evaluation of images artifacts visualization and preservation of important features | 1 day | 4\. Evaluation of images artifacts visualization and preservation of important features and clinical impact on diagnostic ability. |
Countries
United States
Outcome results
None listed