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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Parkinson Disease; Bone Diseases; Dementia; Pulmonary Hypertension; Pulmonary Embolism; Renal Disease; Bone Fracture; Paget Disease; Bone Lesion
• Intervention / Treatment: Device: CZT SPECT imaging

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: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14033
      • CHU de Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CZT SPECT Image Quality	Quality of acquired SPECT images from the CZT SPECT camera	1 day
Comparative Quality of CZT and Anger SPECT Images	Quality of acquired CZT SPECT images in comparison to the quality of images obtained from a conventional Anger gamma camera	1 day
Safety of the CZT SPECT Camera	Incidence of device related Adverse Events occurring during clinical use of the Spectrum Dynamics Multi-purpose CZT SPECT camera	Through study completion; anticipated to be 24 months
Safety of the CZT SPECT Camera During Imaging Procedures	Incidence of peri-procedural Adverse Events	1 day
CZT SPECT-CT Image Quality	Quality of acquired SPECT-CT images from the CZT SPECT-CT camera	1 day
Comparative Quality of CZT SPECT-CT and Anger SPECT Images	Quality of acquired CZT SPECT-CT images in comparison to the quality of images obtained from a conventional Anger gamma camera	1 day
Safety of the CZT SPECT-CT Camera	Incidence of device related Adverse Events occurring during clinical use of the Spectrum Dynamics Multi-purpose CZT SPECT-CT camera	Through study completion; anticipated to be 24 months
Safety of the CZT SPECT-CT Camera During Imaging Procedures	Incidence of peri-procedural Adverse Events	1 day

Collaborators and Investigators

• Sponsor: Spectrum Dynamics
• Collaborators: University Hospital, Caen
• Investigators: Principal Investigator: Denis Agostini, MD.PhD, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Musculoskeletal Diseases; Embolism and Thrombosis; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Hypertension; Heart Diseases; Embolism; Parkinson Disease; Fractures, Bone; Hypertension, Pulmonary; Bone Diseases; Pulmonary Embolism
• Other Study ID Numbers: SD-MPC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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