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

Overview

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.

Full Title of Study: “A Prospective Data Collection Study for the Evaluation of Performance and Safety of the Spectrum Dynamics Multi-purpose CZT SPECT Camera”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 15, 2019

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

  • Device: CZT 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.

Arms, Groups and Cohorts

  • Experimental: CZT SPECT
    • CZT SPECT imaging with/without the addition of CT on the Spectrum Dynamics camera

Clinical Trial Outcome Measures

Primary Measures

  • CZT SPECT Image Acquisition
    • Time Frame: 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
    • Time Frame: 1 day
    • Technical adequacy of acquired CZT SPECT-CT images for demonstrating the location and distribution of gamma ray radionuclides within the body

Secondary Measures

  • CZT SPECT Image Quality
    • Time Frame: 1 day
    • Quality of acquired SPECT images from the CZT SPECT camera
  • Comparative Quality of CZT and Anger SPECT Images
    • Time Frame: 1 day
    • Quality of acquired CZT SPECT images in comparison to the quality of images obtained from a conventional Anger gamma camera
  • Safety of the CZT SPECT Camera
    • Time Frame: 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
    • Time Frame: 1 day
    • Incidence of peri-procedural Adverse Events
  • CZT SPECT-CT Image Quality
    • Time Frame: 1 day
    • Quality of acquired SPECT-CT images from the CZT SPECT-CT camera
  • Comparative Quality of CZT SPECT-CT and Anger SPECT Images
    • Time Frame: 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-CT Camera
    • Time Frame: 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
    • Time Frame: 1 day
    • Incidence of peri-procedural Adverse Events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Spectrum Dynamics
  • Collaborator
    • University Hospital, Caen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Denis Agostini, MD.PhD, Principal Investigator, University Hospital, Caen

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