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Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain.
The study aim is system verification and associated software. Clinical data and clinical feedback will be used for verification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients already scheduled for a FDG test | Subjects will be selected from patients already scheduled for a routine FDG PET/CT test. Only adult patients, 40 years old or older, capable of providing their informed consent, will be selected. Any adult female patients that are pregnant and/or could become pregnant will be excluded. Twenty patients will be recruited. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT imaging | Device | Subjects will be have a PET/CT scan with PCD-1000A following their scheduled routine PET/CT scan. There will be no additional administration of radiopharmaceutical for the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use | PCD-1000A PET/CT system's performance will be evaluated for oncology PET imaging on cancer patients to verify that the system performs as expected. • Verify that all supported clinical protocols from PET acquisition, reconstruction, to presentation (filtering) perform as expected. Images acquired by PCD-1000A PET/CT will be compared with images acquired during a standard-of-care PET/CT scan by a commercially available PET/CT system just prior to imaging with the PCD-1000A PET/CT System. Image quality evaluation will include assessment of uniformity of the liver, delineation of the lungs, presence of artifacts and using Likert scale. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Cancer Patients, 40 years or older, scheduled for a standard-of-care PET/CT scan.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steinberg Diagnostic Medical Imaging Centers | Henderson | Nevada | 89052 | United States |
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