Cancer Patients
Conditions
Brief summary
Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain. * Define and confirm all supported clinical protocols * Evaluate performance
Detailed description
The study aim is system verification and associated software. Clinical data and clinical feedback will be used for verification.
Interventions
DEVICEPET/CT imaging
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.
Sponsors
Canon Medical Systems, USA
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients already scheduled for an FDG test at SDMI * 40 years and older * Capable of providing their informed consent
Exclusion criteria
* Patients not scheduled for an FDG test at SDMI * 39 years or younger * Adult female patients that are and/or could become pregnant * Not capable of providing their informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use | 3 months | 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. |
Countries
United States
Outcome results
None listed