Parkinson Disease
Conditions
Keywords
Parkinson Disease, DaTSCAN™ SPECT/CT scintigraphy, Semiconductor CZT camera with large field
Brief 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. 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: 1. for the diagnosis of Parkinson's disease or related diseases when in doubt with an essential tremor (4) or 2. 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)
Interventions
PROCEDUREDaTSCAN SPECT/CT in VERITON-CT camera
the intervention is based on two recordings in camera VERITON-CT ; the first, in focus striatum mode and the second in brain focus mode
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of concordance (Kappa) of the exams results of different records | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of concordance (Kappa) of the exams results of different recordings | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| quality scores of images from conventional camera and from VERITON (striatum) | 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 |
| recording activity in striatal area for the images from conventional camera and from VERITON (striatum) | 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 |
| score of diagnosis agreement for the images interpretation by 3 physicians | 18 months | The agreement will be between conventional record and striatum focus record with VERITON camera |
| Degree of concordance (Kappa) of the exams results of different recordings | 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 |
| quality scores of images from conventional camera and from VERITON (brain) | 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 |
| recording activity in striatal area for the images from conventional camera and from VERITON (brain) | 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 |
| diagnosis agreement for the interpretation by 3 physicians between conventional and VERITON (brain) | 18 months | The agreement will be between conventional record and brain focus record with VERITON camera |
| uptake ratios on the conventional record and on the focus brain record with VERITON | 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 |
| ratios of uptake obtained with conventional camera and on the striatum focus record with VERITON-CT | 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 |
Countries
France
Outcome results
None listed