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

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ClinicalTrials.gov Identifier: NCT03438123
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
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 camera. All subjects will undergo routine clinical Anger SPECT imaging and an additional SPECT acquisition on the CZT SPECT 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

Intervention Details:
  • 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


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 6 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 periprocedural Adverse Events



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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 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


Contacts
Contact: Justine P McQuillan, MBA +447429297551 justinem@spectrum-dynamics.com

Locations
France
CHU de Caen Recruiting
Caen, Normandy, France, 14033
Contact: Denis Agostini, MD.PhD    +33 231 063 246    agostini-de@chu-caen.fr   
Sub-Investigator: Blandine Enilorac, MD         
Principal Investigator: Denis Agostini, MD.PhD         
Sponsors and Collaborators
Spectrum Dynamics
University Hospital, Caen
Investigators
Principal Investigator: Denis Agostini, MD.PhD University Hospital, Caen

Responsible Party: Spectrum Dynamics
ClinicalTrials.gov Identifier: NCT03438123     History of Changes
Other Study ID Numbers: SD-MPC-01
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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