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

• Sponsor: Spectrum Dynamics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03438123
• Collaborator: University Hospital, Caen (Other)
• Enrollment: 140
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.5
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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.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: Nov 28, 2017
• Actual Primary Completion Date: Oct 15, 2019
• Actual Study Completion Date: Oct 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. CZT SPECT Image Acquisition [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 [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 [1 day]

   Quality of acquired SPECT images from the CZT SPECT camera

2. Comparative Quality of CZT and Anger SPECT Images [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 [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 [1 day]

   Incidence of peri-procedural Adverse Events

5. CZT SPECT-CT Image Quality [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 [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 [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 [1 day]

   Incidence of peri-procedural Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Caen	Caen	Normandy	France	14033

Sponsors and Collaborators

• Spectrum Dynamics
• University Hospital, Caen

Investigators

• Principal Investigator: Denis Agostini, MD.PhD, University Hospital, Caen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spectrum Dynamics
• ClinicalTrials.gov Identifier: NCT03438123
• Other Study ID Numbers: SD-MPC-01
• First Posted: Feb 19, 2018
• Last Update Posted: Oct 21, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Bone Diseases; Hypertension, Pulmonary; Pulmonary Embolism; Parkinson Disease; Heart Diseases; Embolism; Fractures, Bone

Study Results

No Results Posted as of Oct 21, 2019