This study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification of other areas of development required.
Up to 38 subjects may be enrolled to achieve the target number of 30 evaluable subjects. Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced. Subject participation will be deemed complete once the diagnostic and investigational scans are completed. A subject is considered evaluable when images and raw data from the diagnostic single energy cardiac CT scan and raw data from the investigational dual energy cardiac CT scan have been collected successfully and demonstrate a diagnostic interpretation.
Study Type
OBSERVATIONAL
Enrollment
30
After the subject undergoes the clinically prescribed cardiac Computed Tomography (CT) scan for their diagnostic purposes, the investigational Gemstone Spectral Imaging (GSI) scan will be conducted following the diagnostic CT scan utilizing the same contrast administration.
Zürich University Hospital
Zurich, Switzerland
Collect Data
Data will be collected from the scanner for future post-processing and engineering development. There is no analysis planned at this time for the data, simply data collection.
Time frame: through study completion, an average of 1 year
Evaluation- Likert Scale
Complete an image evaluation using a 5 point Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality), done by a qualified cardiac imaging expert.
Time frame: through study completion, an average of 1 year
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