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 ™)
1 other identifier
interventional
96
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Sep 2019
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 10, 2019
CompletedStudy Start
First participant enrolled
September 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2020
CompletedAugust 24, 2022
September 1, 2020
12 months
June 6, 2019
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
16 months
Secondary Outcomes (1)
Degree of concordance (Kappa) of the exams results of different recordings
16 months
Other Outcomes (10)
Degree of concordance (Kappa) of the exams results of different recordings
16 months
Degree of concordance (Kappa) of the exams results of different recordings
16 months after the first enrollment
ratios of uptake obtained with conventional camera and on the striatum focus record with VERITON-CT
immediately after SPECT-CT exam
- +7 more other outcomes
Study Arms (1)
all included patients will have the same procedure
EXPERIMENTALAfter 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
Interventions
the intervention is based on two recordings in camera VERITON-CT ; the first, in focus striatum mode and the second in brain focus mode
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU of Nancy
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 10, 2019
Study Start
September 5, 2019
Primary Completion
September 3, 2020
Study Completion
September 3, 2020
Last Updated
August 24, 2022
Record last verified: 2020-09