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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

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.

Condition or disease Intervention/treatment Phase
Dementia Parkinson Disease Pulmonary Hypertension Heart Diseases Paget Disease Bone Diseases Bone Fracture Renal Disease Pulmonary Embolism Bone Lesion Device: CZT SPECT imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
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
Official Title: A Prospective Data Collection Study for the Evaluation of Performance and Safety of the Spectrum Dynamics Multi-purpose CZT SPECT Camera
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CZT SPECT
CZT SPECT imaging with/without the addition of CT on the Spectrum Dynamics camera
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.




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. CZT SPECT Image Quality [ Time Frame: 1 day ]
    Quality of acquired SPECT images from the CZT SPECT camera

  2. 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

  3. 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

  4. Safety of the CZT SPECT Camera During Imaging Procedures [ Time Frame: 1 day ]
    Incidence of peri-procedural Adverse Events

  5. CZT SPECT-CT Image Quality [ Time Frame: 1 day ]
    Quality of acquired SPECT-CT images from the CZT SPECT-CT camera

  6. 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

  7. 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

  8. Safety of the CZT SPECT-CT Camera During Imaging Procedures [ Time Frame: 1 day ]
    Incidence of peri-procedural Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438123


Locations
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France
CHU de Caen
Caen, Normandy, France, 14033
Sponsors and Collaborators
Spectrum Dynamics
University Hospital, Caen
Investigators
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Principal Investigator: Denis Agostini, MD.PhD University Hospital, Caen
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Responsible Party: Spectrum Dynamics
ClinicalTrials.gov Identifier: NCT03438123    
Other Study ID Numbers: SD-MPC-01
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Bone Diseases
Hypertension, Pulmonary
Pulmonary Embolism
Parkinson Disease
Heart Diseases
Embolism
Fractures, Bone
Vascular Diseases
Cardiovascular Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Musculoskeletal Diseases
Wounds and Injuries