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

NCT ID: NCT03438123

Last Updated: 2019-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2019-10-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CZT SPECT

CZT SPECT imaging with/without the addition of CT on the Spectrum Dynamics camera

Group Type EXPERIMENTAL

CZT SPECT imaging

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role collaborator

Spectrum Dynamics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denis Agostini, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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CHU de Caen

Caen, Normandy, France

Site Status

Countries

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France

Other Identifiers

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SD-MPC-01

Identifier Type: -

Identifier Source: org_study_id

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