- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03980418
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam (VERIDAT)
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.
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™
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Vandoeuvre les Nancy cedex, France, 54511
- CHRU of Nancy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: all included patients will have the same procedure
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
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the intervention is based on two recordings in camera VERITON-CT ; the first, in focus striatum mode and the second in brain focus mode
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of concordance (Kappa) of the exams results of different recordings
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 brain focus mode
|
16 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of concordance (Kappa) of the exams results of different recordings
Time Frame: 16 months
|
comparison between the exam results (positive diagnosis of Parkinson disease versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in striatum focus mode
|
16 months
|
Degree of concordance (Kappa) of the exams results of different recordings
Time Frame: 16 months after the first enrollment
|
comparison between the exam results (positive diagnosis of Lewy bodies dementia versus differential diagnosis) in conventional camera and the one obtained with the VERITON-CT in striatum focus mode
|
16 months after the first enrollment
|
ratios of uptake obtained with conventional camera and on the striatum focus record with VERITON-CT
Time Frame: immediately after SPECT-CT exam
|
the uptake ratios are:caudate nuclei/occipital cortex, putamen/occipital cortex, to the right and caudate nuclei/medium cingulate cortex, putamen/medium cingulate cortex to left, obtained with conventional camera and on the striatum focus record with VERITON-CT camera
|
immediately after SPECT-CT exam
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quality scores of images from conventional camera and from VERITON (striatum)
Time Frame: immediately after SPECT-CT exam
|
0= very bad quality and impossible to do a diagnosis, 1=bad quality and difficult diagnosis, 2= medium quality, 3 = good quality and 4= excellent quality
|
immediately after SPECT-CT exam
|
recording activity in striatal area for the images from conventional camera and from VERITON (striatum)
Time Frame: immediately after SPECT-CT exams
|
recorded activities will be reported by injected MBq for the images obtained with the conventional camera and with VERITON striatum focus record
|
immediately after SPECT-CT exams
|
score of diagnosis agreement for the images interpretation by 3 physicians
Time Frame: 18 months
|
The agreement will be between conventional record and striatum focus record with VERITON camera
|
18 months
|
uptake ratios on the conventional record and on the focus brain record with VERITON
Time Frame: after each SPECT/CT exams
|
the uptake ratios are:caudate nuclei/occipital cortex, putamen/occipital cortex, to the right and caudate nuclei/medium cingulate cortex, putamen/medium cingulate cortex to left, obtained with conventional camera and on the brain focus record with VERITON-CT camera
|
after each SPECT/CT exams
|
quality scores of images from conventional camera and from VERITON (brain)
Time Frame: immediately after SPECT-CT exams
|
0= very bad quality and impossible to do a diagnosis, 1=bad quality and difficult diagnosis, 2= medium quality, 3 = good quality and 4= excellent quality
|
immediately after SPECT-CT exams
|
recording activity in striatal area for the images from conventional camera and from VERITON (brain)
Time Frame: 18 months
|
recorded activities will be reported by injected MegaBecquerel (MBq) for the images obtained with the conventional camera and with VERITON brain focus record
|
18 months
|
diagnosis agreement for the interpretation by 3 physicians between conventional and VERITON (brain)
Time Frame: 18 months
|
The agreement will be between conventional record and brain focus record with VERITON camera
|
18 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSS2019/VERIDAT-VERGER-VS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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