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.
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.
Study Type
OBSERVATIONAL
Enrollment
126
Paired side be side evaluation Each reader will assess- Image Quality (IQ) \& Diagnostic Confidence Ratings will be recorded using a 5-point Likert scale
Montefiore
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jefferson Einstein
Philadelphia, Pennsylvania, United States
Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images
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.
Time frame: 1 day
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).
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).
Time frame: 1 day
Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images
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.
Time frame: 1 day
Evaluation of the success rate for Spectral Precise Image reconstruction
2\. To evaluate the success rate (%) for Spectral Precise Image reconstructions
Time frame: 1 day
Evaluation of the interobserver agreement level for the Co-Primary endpoints
3\. The interobserver agreement level for the Co-Primary endpoints is more than 0.8.
Time frame: 1 day
Evaluation of images artifacts visualization and preservation of important features
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4\. Evaluation of images artifacts visualization and preservation of important features and clinical impact on diagnostic ability.
Time frame: 1 day