Clinical trial NCT03438123: Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera
Official title: A Prospective Data Collection Study for the Evaluation of Performance and Safety of the Spectrum Dynamics Multi-purpose CZT SPECT Camera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Parkinson Disease
Pulmonary Hypertension
Heart Diseases
Paget Disease
Bone Diseases
Bone Fracture
Renal Disease
Pulmonary Embolism
Bone Lesion
Lead sponsor: Spectrum Dynamics
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Caen
First posted: 2018-02-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: CZT SPECT Image Acquisition
timeFrame: 1 day
measure: CZT SPECT-CT Image Acquisition
timeFrame: 1 day
Secondary outcomes:
measure: CZT SPECT Image Quality
timeFrame: 1 day
measure: Comparative Quality of CZT and Anger SPECT Images
timeFrame: 1 day
measure: Safety of the CZT SPECT Camera
timeFrame: Through study completion; anticipated to be 24 months
measure: Safety of the CZT SPECT Camera During Imaging Procedures
timeFrame: 1 day
measure: CZT SPECT-CT Image Quality
timeFrame: 1 day
measure: Comparative Quality of CZT SPECT-CT and Anger SPECT Images
timeFrame: 1 day
measure: Safety of the CZT SPECT-CT Camera
timeFrame: Through study completion; anticipated to be 24 months
measure: Safety of the CZT SPECT-CT Camera During Imaging Procedures
timeFrame: 1 day
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
state: Normandy
Study officials:
affiliation: University Hospital, Caen
name: Denis Agostini, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: