Parkinson DiseaseVERIDATNCT03980418
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
A study testing DaTSCAN SPECT/CT in VERITON-CT camera in people with Parkinson Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The semiconductor (cadmium-zinc-telluride, CZT) cameras significantly increase detection sensitivity in Single Photon Emission Computer Tomoscintigraphy (SPECT)(1) . The clinical routine applications of these cameras are today mainly limited to myocardial tomoscintigraphy with CZT dedicated cameras. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- DaTSCAN SPECT/CT in VERITON-CT camera
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2019to 3 Sep 2020
- 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
- all patients over 18 years sent to Datscan SPECT/CT
- patients understanding and having signed the informed consent form.
- without contraindication to have the scintigraphy
- patient subject to a medical benefits scheme
Who cannot join
- known allergy to the one of the components of Datscan
- pregnant, parturient or breastfeeding woman
- major person under legal protection (any form of public guardianship)
- major person unable to express consent
- person deprived of liberty due to judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of DaTSCAN ™ Cerebral SPECT Recorded by Conventional Anger Cameras and Semiconductor Camera (VERITON-CT ™)
The semiconductor (cadmium-zinc-telluride, CZT) cameras significantly increase detection sensitivity in Single Photon Emission Computer Tomoscintigraphy (SPECT)(1) . The clinical routine applications of these cameras are today mainly limited to myocardial tomoscintigraphy with CZT dedicated cameras. Several studies whose one was done in Hospital of Nancy, made it possible to demonstrate a good diagnosis agreement between conventional cameras and semiconductor cameras in this indication, with better image quality obtained with semiconductor cameras (2). Today, so-called "wide field" semiconductor cameras are available in the clinic and allow for any type of SPECT examination. A comparative study between conventional and semiconductor cameras has been conducted for bone scintigraphy, and shows diagnostic superiority with this new type of camera (3).
In addition, the new VERITON-CT ™ (Spectrum Dynamics Medical) camera has 12 mobile CZT-based detectors positioned around the patient allowing tomographic acquisitions and focusing the acquisition on the organ studied. This camera has a sensitivity of detection higher than that of conventional cameras and thus reduces the activity injected into the patient and / or the recording time.
Read more
To date, no study has compared the two types of cameras in nuclear neurology and in particular, for the SPECT DaTSCAN ™ imaging of the pre-synaptic dopaminergic pathway.
DaTSCAN ™ exam is used in clinical routine:
- for the diagnosis of Parkinson's disease or related diseases when in doubt with an essential tremor (4) or
- if suspicion of Lewy body disease, if in doubt with Alzheimer's disease (5). If the interpretation of DaTSCAN ™ exam is first visual, the quantification may increase accuracy diagnosis (6). Also, the database creation specific to each type of camera is recommended(7).
The purpose of this study is to compare the diagnostically relevant informations and the quantitative analysis provided by the DaTSCAN™ SPECT, recorded on the conventional camera and recorded on the semiconductor camera VERITON-CT™
Read the detailed description
The clinical study is monocentric, interventional, non randomized, with minimal risk and constraints.
All patients going to the nuclear medicine department for a DaTSCAN exam will be able to participate in this study if they understood study informations given by the physician and if they signed the inform consent.
In first, patients will have a DaTSCAN™ SPECT on a conventional camera and after, they will have DaTSCAN™ SPECT on VERITON-CT™ camera with two records: one in focus striatum mode and the second in focus brain mode.
The attenuation correction will be made with the computer tomography (CT) recorded at the same time as the SPECT (SPECT/CT)
- Conditions
- Parkinson Disease
- Being tested
- DaTSCAN SPECT/CT in VERITON-CT camera
- Keywords
- Parkinson Disease, DaTSCAN™ SPECT/CT scintigraphy, Semiconductor CZT camera "with large field"
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaTSCAN SPECT/CT in VERITON-CT cameraProcedure or surgery
the intervention is based on two recordings in camera VERITON-CT ; the first, in focus striatum mode and the second in brain focus mode
| Study group | Role | What they receive |
|---|---|---|
| all included patients will have the same procedure | Experimental | After the conventional DaTSCAN SPECT/CT exam in conventional camera, all patients included will have two recordings of DaTSCAN SPECT/CT in semiconductor CZT (cadmium zinc telluride) camera; one focused on the striatum and the other focused on the total brain Receives: Procedure: DaTSCAN SPECT/CT in VERITON-CT camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of concordance (Kappa) of the exams results of different records
comparison between the exam results (positive diagnosis of Parkinson disease or Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in striatum focus mode
Measured: 16 months
Secondary outcomes (1)
Degree of concordance (Kappa) of the exams results of different recordings
comparison between the exam results (positive diagnosis of Parkinson disease or Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in brain focus mode
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start5 Sep 2019
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980418
- Sponsor's protocol ID
- PSS2019/VERIDAT-VERGER-VS
- Acronym
- VERIDAT
- Status last verified
- Sep 2020
- First submitted
- 6 Jun 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of DaTSCAN ™ Cerebral SPECT Recorded by Conventional Anger Cameras and Semiconductor Camera (VERITON-CT ™)
- ClinicalTrials.gov ID
- NCT03980418
- Acronym / sponsor ID
- VERIDAT / PSS2019/VERIDAT-VERGER-VS
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, DaTSCAN™ SPECT/CT scintigraphy, Semiconductor CZT camera "with large field"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 10 Jun 2019 (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.
The semiconductor (cadmium-zinc-telluride, CZT) cameras significantly increase detection sensitivity in Single Photon Emission Computer Tomoscintigraphy (SPECT)(1) . The clinical routine applications of these cameras are today mainly limited to myocardial tomoscintigraphy with CZT dedicated cameras. Several studies whose one was done in Hospital of Nancy, made it possible to demonstrate a good diagnosis agreement between conventional cameras and semiconductor cameras in this indication, with better image quality obtained with semiconductor cameras (2). Today, so-called "wide field" semiconductor cameras are available in the clinic and allow for any type of SPECT examination. A comparative study between conventional and semiconductor cameras has been conducted for bone scintigraphy, and shows diagnostic superiority with this new type of camera (3).
In addition, the new VERITON-CT ™ (Spectrum Dynamics Medical) camera has 12 mobile CZT-based detectors positioned around the patient allowing tomographic acquisitions and focusing the acquisition on the organ studied. This camera has a sensitivity of detection higher than that of conventional cameras and thus reduces the activity injected into the patient and / or the recording time.
To date, no study has compared the two types of cameras in nuclear neurology and in particular, for the SPECT DaTSCAN ™ imaging of the pre-synaptic dopaminergic pathway.
DaTSCAN ™ exam is used in clinical routine:
- for the diagnosis of Parkinson's disease or related diseases when in doubt with an essential tremor (4) or
- if suspicion of Lewy body disease, if in doubt with Alzheimer's disease (5). If the interpretation of DaTSCAN ™ exam is first visual, the quantification may increase accuracy diagnosis (6). Also, the database creation specific to each type of camera is recommended(7).
The purpose of this study is to compare the diagnostically relevant informations and the quantitative analysis provided by the DaTSCAN™ SPECT, recorded on the conventional camera and recorded on the semiconductor camera VERITON-CT™
Detailed description
The clinical study is monocentric, interventional, non randomized, with minimal risk and constraints.
All patients going to the nuclear medicine department for a DaTSCAN exam will be able to participate in this study if they understood study informations given by the physician and if they signed the inform consent.
In first, patients will have a DaTSCAN™ SPECT on a conventional camera and after, they will have DaTSCAN™ SPECT on VERITON-CT™ camera with two records: one in focus striatum mode and the second in focus brain mode.
The attenuation correction will be made with the computer tomography (CT) recorded at the same time as the SPECT (SPECT/CT)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all included patients will have the same procedure | Experimental | Procedure: DaTSCAN SPECT/CT in VERITON-CT cameraAfter the conventional DaTSCAN SPECT/CT exam in conventional camera, all patients included will have two recordings of DaTSCAN SPECT/CT in semiconductor CZT (cadmium zinc telluride) camera; one focused on the striatum and the other focused on the total brain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- all patients over 18 years sent to Datscan SPECT/CT
- patients understanding and having signed the informed consent form.
- without contraindication to have the scintigraphy
- patient subject to a medical benefits scheme
Key exclusion criteria (5 listed)
- known allergy to the one of the components of Datscan
- pregnant, parturient or breastfeeding woman
- major person under legal protection (any form of public guardianship)
- major person unable to express consent
- person deprived of liberty due to judicial or administrative decision.
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 |
|---|---|---|
| DaTSCAN SPECT/CT in VERITON-CT camerathe intervention is based on two recordings in camera VERITON-CT ; the first, in focus striatum mode and the second in brain focus mode | Procedure or surgery | all included patients will have the same procedure |
Primary outcome
Degree of concordance (Kappa) of the exams results of different records
Time frame: 16 months
comparison between the exam results (positive diagnosis of Parkinson disease or Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in striatum focus mode
1 secondary outcome
Degree of concordance (Kappa) of the exams results of different recordings
Time frame: 16 months
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 24 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DaTSCAN SPECT/CT in VERITON-CT camera in people with Parkinson Disease, run by Central Hospital, Nancy, France 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 4 inclusion and 5 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 24 Aug 2022. 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?
Degree of concordance (Kappa) of the exams results of different records (time frame: 16 months). 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 24 Aug 2022.