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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438123
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
University Hospital, Caen
Information provided by (Responsible Party):
Spectrum Dynamics

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date October 21, 2019
Actual Study Start Date  ICMJE November 28, 2017
Actual Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • 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 6 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 periprocedural Adverse Events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera
Official Title  ICMJE A Prospective Data Collection Study for the Evaluation of Performance and Safety of the Spectrum Dynamics Multi-purpose CZT SPECT Camera
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Dementia
  • Parkinson Disease
  • Pulmonary Hypertension
  • Heart Diseases
  • Paget Disease
  • Bone Diseases
  • Bone Fracture
  • Renal Disease
  • Pulmonary Embolism
  • Bone Lesion
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: CZT SPECT
CZT SPECT imaging with/without the addition of CT on the Spectrum Dynamics camera
Intervention: Device: CZT SPECT imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2019)
140
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
60
Actual Study Completion Date  ICMJE October 15, 2019
Actual Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438123
Other Study ID Numbers  ICMJE SD-MPC-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Spectrum Dynamics
Study Sponsor  ICMJE Spectrum Dynamics
Collaborators  ICMJE University Hospital, Caen
Investigators  ICMJE
Principal Investigator: Denis Agostini, MD.PhD University Hospital, Caen
PRS Account Spectrum Dynamics
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP