Clinical Feasibility and Evaluation of Silicon Photon Counting CT

Study Overview
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Brief Summary
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The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.

Detailed Description
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Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise that will evaluate the product and how this photon-counting CT technology can be used to reduce the overall radiation dose in CT imaging, and enhance clinical applications for CT technology. This data and analysis will help support regulatory submission.

Official Title
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Clinical Feasibility and Evaluation of Silicon Photon Counting CT

Conditions
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CT Photon-Counting

Intervention / Treatment
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* Device: CT Photon-Counting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Who are 18 years of age or older Able to sign and date the informed consent form Who have in the past 120 days or will in the future 30 days undergo a clinically-indicated CT exam of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior scheduled exam Exclusion Criteria: Who are pregnant or lactating; Who were previously enrolled in this study; For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel; Who need urgent or emergent care; Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR Who are unwilling to have GEHC personnel present for the CT exam.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject's Scanned with Investigational Device<br> | Device: CT Photon-Counting<br>* Enrolled subjects will complete an exam using the photon-counting CT, with or without IV contract as indicated. Images will then be compared with the previously acquired CT conducted as standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collection | Number of Participants with raw investigational photon-counting CT scan data along with prior standard of care diagnostic CT exam data/images | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | Reconstructed images produced from the raw investigational photon-counting CT scan will be scored for image quality using a Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality) | 1 year |