DementiaNCT03438123
Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera
A study testing CZT SPECT imaging in people with Dementia and Parkinson Disease, run by Spectrum Dynamics at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Parkinson Disease, Pulmonary Hypertension
- What is being tested?
- CZT SPECT imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2017to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is clinically referred for scintigraphy using a radiopharmaceutical in the energy range of 40 - 220 keV emission
- Patient is aged ≥18 years
- Patient condition is stable
- 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
- Patient must be willing and able to provide written informed consent
- Patient must be affiliated to a social security scheme
Who cannot join
- Patient with unstable medical condition
- Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- Patient is contra-indicated to undergo the scintigraphy imaging procedure for which they have been clinically referred
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia, Parkinson Disease, Pulmonary Hypertension, Heart Diseases, Paget Disease, Bone Diseases
- Being tested
- CZT SPECT imaging
- Medical subject headings
- Dementia, Parkinson Disease, Hypertension, Pulmonary, Heart Diseases, Bone Diseases, Fractures, Bone, Kidney Diseases, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CZT SPECT imagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CZT SPECT | Experimental | CZT SPECT imaging with/without the addition of CT on the Spectrum Dynamics camera Receives: Device: CZT SPECT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
CZT SPECT Image Acquisition
Technical adequacy of acquired CZT SPECT images for demonstrating the location and distribution of gamma ray radionuclides within the body
Measured: 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
Measured: 1 day
Secondary outcomes (8)
CZT SPECT Image Quality
Quality of acquired SPECT images from the CZT SPECT camera
Measured: 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
Measured: 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
Measured: Through study completion; anticipated to be 24 months
Safety of the CZT SPECT Camera During Imaging Procedures
Incidence of peri-procedural Adverse Events
Measured: 1 day
CZT SPECT-CT Image Quality
Quality of acquired SPECT-CT images from the CZT SPECT-CT camera
Measured: 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
Measured: 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
Measured: Through study completion; anticipated to be 24 months
Safety of the CZT SPECT-CT Camera During Imaging Procedures
Incidence of peri-procedural Adverse Events
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start28 Nov 2017
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Caen
- Responsible party
- Sponsor
- Investigators
- Denis Agostini, MD.PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438123
- Sponsor's protocol ID
- SD-MPC-01
- Status last verified
- Oct 2019
- First submitted
- 6 Feb 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Data Collection Study for the Evaluation of Performance and Safety of the Spectrum Dynamics Multi-purpose CZT SPECT Camera
- ClinicalTrials.gov ID
- NCT03438123
- Acronym / sponsor ID
- SD-MPC-01
- Conditions
- Dementia, Parkinson Disease, Pulmonary Hypertension, Heart Diseases, Paget Disease, Bone Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Spectrum DynamicsIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Caen
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| CZT SPECT | Experimental | Device: CZT SPECT imagingCZT SPECT imaging with/without the addition of CT on the Spectrum Dynamics camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is clinically referred for scintigraphy using a radiopharmaceutical in the energy range of 40 - 220 keV emission
- Patient is aged ≥18 years
- Patient condition is stable
- 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
- Patient must be willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Patient with unstable medical condition
- Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- Patient is contra-indicated to undergo the scintigraphy imaging procedure for which they have been clinically referred
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CZT SPECT imagingAcquisition 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. | Device | CZT SPECT |
Primary outcome
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
CZT SPECT-CT Image Acquisition
Time frame: 1 day
Technical adequacy of acquired CZT SPECT-CT images for demonstrating the location and distribution of gamma ray radionuclides within the body
8 secondary outcomes
CZT SPECT Image Quality
Time frame: 1 day
Comparative Quality of CZT and Anger SPECT Images
Time frame: 1 day
Safety of the CZT SPECT Camera
Time frame: Through study completion; anticipated to be 24 months
Safety of the CZT SPECT Camera During Imaging Procedures
Time frame: 1 day
CZT SPECT-CT Image Quality
Time frame: 1 day
Comparative Quality of CZT SPECT-CT and Anger SPECT Images
Time frame: 1 day
Safety of the CZT SPECT-CT Camera
Time frame: Through study completion; anticipated to be 24 months
Safety of the CZT SPECT-CT Camera During Imaging Procedures
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Agostini, MD.PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CZT SPECT imaging in people with Dementia and Parkinson Disease, run by Spectrum Dynamics at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CZT SPECT Image Acquisition (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.