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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438123
• Other study ID #: SD-MPC-01
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: October 2019
• Source: Spectrum Dynamics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Fracture
• Bone Lesion
• Dementia
• Embolism
• Fractures, Bone
• Heart Diseases
• Hypertension, Pulmonary
• Paget Disease
• Parkinson Disease
• Pulmonary Embolism
• Pulmonary Hypertension
• Renal Disease

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Caen	Caen	Normandy

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Dynamics	University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	CZT SPECT Image Quality	Quality of acquired SPECT images from the CZT SPECT camera	1 day
Secondary	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
Secondary	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
Secondary	Safety of the CZT SPECT Camera During Imaging Procedures	Incidence of peri-procedural Adverse Events	1 day
Secondary	CZT SPECT-CT Image Quality	Quality of acquired SPECT-CT images from the CZT SPECT-CT camera	1 day
Secondary	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
Secondary	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
Secondary	Safety of the CZT SPECT-CT Camera During Imaging Procedures	Incidence of peri-procedural Adverse Events	1 day