Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera

Not Applicable

Completed

• Conditions: Dementia; Parkinson Disease; Pulmonary Hypertension; Paget Disease; Bone Fracture; Bone Lesion; Heart Diseases; Renal Disease; Bone Diseases; Pulmonary Embolism
• Interventions: Device: CZT SPECT imaging

• Registration Number: NCT03438123
• Lead Sponsor: Spectrum Dynamics

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.

Study Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Status Verified: 2019-10
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CZT SPECT	CZT SPECT imaging	CZT SPECT imaging with/without the addition of CT on the Spectrum Dynamics camera

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
CZT SPECT Image Quality	1 day	Quality of acquired SPECT images from the CZT SPECT camera
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
CZT SPECT-CT Image Quality	1 day	Quality of acquired SPECT-CT images from the CZT SPECT-CT camera
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
Safety of the CZT SPECT Camera During Imaging Procedures	1 day	Incidence of peri-procedural Adverse Events
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

Trial Locations

Locations (1)

CHU de Caen; 🇫🇷 Caen, Normandy, France