Bone Diseases, Bone Fracture, Bone Lesion, Dementia, Heart Diseases, Paget Disease, Parkinson Disease, Pulmonary Embolism, Pulmonary Hypertension, Renal Disease
Conditions
Brief summary
This study evaluates SPECT image data acquired from Spectrum Dynamics' multi-purpose CZT SPECT-CT camera. All subjects will undergo routine clinical Anger SPECT imaging and an additional SPECT acquisition on the CZT SPECT camera. Additionally some subjects will undergo CT on the CZT SPECT-CT camera. The quality of images from each device will be compared.
Detailed description
The Spectrum Dynamics Multi-purpose CZT SPECT camera is a whole body SPECT (single photon emission computed tomography) scanner which utilises solid-state cadmium zinc telluride (CZT) detectors to visualise injected, or otherwise introduced, radioactivity in the human body. The CZT SPECT camera detects the location and distribution of gamma-emitting radionuclides in the body and produces 3 dimensional cross-sectional images through computed reconstruction of the data for the purpose of determining various metabolic and physiologic functions in the human body. In comparison to conventional sodium iodide (NaI) gamma camera (or Anger camera) technology, solid state CZT technology offers improved energy, spatial and temporal resolution, and higher count rates. Improvements in energy resolution and sensitivity thus enable the potential capability for enhanced quantification, simultaneous dual isotope imaging and dynamic imaging acquisition. The camera system also incorporates a multi-slice CT gantry and acquired SPECT and CT images can be combined to improve image reconstruction by allowing fusion of CT and SPECT image data for anatomic localisation referencing and CT attenuation correction of the SPECT image data.
Interventions
DEVICECZT SPECT imaging
Acquisition of SPECT (single photon emission computed tomography) imaging utilising a camera system with solid-state cadmium zinc telluride (CZT) detectors to visualise injected, or otherwise introduced, radioactivity in the human body.
Sponsors
University Hospital, Caen
Spectrum Dynamics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All subjects undergo baseline clinically referred routine nuclear scintigraphy imaging and sequential imaging on the CZT SPECT investigational device following a single dose of radiopharmaceutical. Some subjects will additionally undergo CT on the CZT SPECT-CT investigational device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is clinically referred for scintigraphy using a radiopharmaceutical in the energy range of 40 - 220 keV emission 2. Patient is aged ≥18 years 3. Patient condition is stable 4. Patient is willing and able to undergo image acquisition on the MPC CZT SPECT camera with integrated CT in addition to standard clinical scintigraphy procedure 5. Patient must be willing and able to provide written informed consent 6. Patient must be affiliated to a social security scheme
Exclusion criteria
1. Patient with unstable medical condition 2. Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods 3. Patient is contra-indicated to undergo the scintigraphy imaging procedure for which they have been clinically referred
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CZT SPECT Image Acquisition | 1 day | Technical adequacy of acquired CZT SPECT images for demonstrating the location and distribution of gamma ray radionuclides within the body |
| CZT SPECT-CT Image Acquisition | 1 day | Technical adequacy of acquired CZT SPECT-CT images for demonstrating the location and distribution of gamma ray radionuclides within the body |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the CZT SPECT Camera | Through study completion; anticipated to be 24 months | Incidence of device related Adverse Events occurring during clinical use of the Spectrum Dynamics Multi-purpose CZT SPECT camera |
| Safety of the CZT SPECT Camera During Imaging Procedures | 1 day | Incidence of peri-procedural Adverse Events |
| CZT SPECT-CT Image Quality | 1 day | Quality of acquired SPECT-CT images from the CZT SPECT-CT camera |
| CZT SPECT Image Quality | 1 day | Quality of acquired SPECT images from the CZT SPECT camera |
| Safety of the CZT SPECT-CT Camera | Through study completion; anticipated to be 24 months | Incidence of device related Adverse Events occurring during clinical use of the Spectrum Dynamics Multi-purpose CZT SPECT-CT camera |
| Safety of the CZT SPECT-CT Camera During Imaging Procedures | 1 day | Incidence of peri-procedural Adverse Events |
| Comparative Quality of CZT SPECT-CT and Anger SPECT Images | 1 day | Quality of acquired CZT SPECT-CT images in comparison to the quality of images obtained from a conventional Anger gamma camera |
| Comparative Quality of CZT and Anger SPECT Images | 1 day | Quality of acquired CZT SPECT images in comparison to the quality of images obtained from a conventional Anger gamma camera |
Countries
France
Outcome results
None listed