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The intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. This study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. The goal of this study is to collect a library of image data from the hybrid PET/CT system to be used for evaluation and optimization of the image quality of the system in a clinical setting and as comparison with the standard of care hybrid PET/CT system, Discovery MI 25m (DMI5R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMNI PET/CT scan first | Other |
| |
| DMI PET/CT scan first | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional PET/CT Scan | Device | The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation- Likert Scale | The primary endpoints of this study are completed image evaluation using a 1 point Likert Scale of the OMNI PET/CT system including analysis, reading, and scoring utilizing a Likert Scale, by three (3) qualified Nuclear Medicine physicians. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection | PET/CT Image collection | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian W Thomsen | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Healthcare Campus | Haifa | 3109601 | Israel |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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