Cancer
Conditions
Brief summary
The primary purpose of the study is to obtain sample clinical images that are evaluated by physicians in support of regulatory submissions. Additionally, the study will provide data for current and future product development and it will provide clinical images and data for marketing use.
Interventions
DEVICEDiscovery NM/CT 670 CZT Imaging Scan
At a single visit, subjects will undergo nuclear medicine scintigraphy imaging scanning on the investigational GE Discovery 670 NM/CT CZT (with CZT) device and the commercial GE Discovery 670c (without CZT).
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. are 18-years old and older; 2. is able to sign and date the informed consent form; AND 3. have been prescribed by a physician a nuclear medicine exam that is within the intended use of the device.
Exclusion criteria
1. Patients who were referred for dynamic nuclear medicine scan because of the need to be injected twice (once for the conventional acquisition and once for the investigational device) that would result in an increase dose burden on patient. 2. Pregnant or lactating women 3. Who were previously enrolled in this study; 4. Who have contraindication for the radiopharmaceutical 5. Who have any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Image Quality | 12 weeks | Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale |
| Image Resolution | 12 weeks | Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale |
Countries
Israel
Outcome results
None listed