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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject's Scanned with Investigational Device | Eligible and consented subjects will be scanned using the investigational Pluto Photon-Counting CT system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Photon-Counting | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population will consist of adults that are 18-years of age or older, and who have undergone a prior clinically-indicated CT exam of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and/or extremities.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Thomsen | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
Scan data will be shared with other researchers but all will be completely deidentified.
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