Clinical Feasibility and Evaluation of Silicon Photon Counting CT
Study Details
Study Description
Brief Summary
The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subject's Scanned with Investigational Device
|
Device: CT Photon-Counting
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.
|
Outcome Measures
Primary Outcome Measures
- Evaluate feasibility of the photon-counting CT in a clinical setting [1 year]
The primary objective of this study is to collect and evaluate raw CT scan data collected using the photon-counting CT.
Secondary Outcome Measures
- Collect feedback on performance and images generated on the photon-counting CT [1 year]
Gather feedback on the performance and image quality of the reconstructed images produced by using the photon-counting CT.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Who are 18 years of age or older
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Able to sign and date the informed consent form
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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:
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Who are pregnant or lactating;
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Who were previously enrolled in this study;
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For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents
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For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
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Who need urgent or emergent care;
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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
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Who are unwilling to have GEHC personnel present for the CT exam.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Palo Alto | California | United States | 94304 |
Sponsors and Collaborators
- GE Healthcare
- Stanford University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23000861577