Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System

Study Overview
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Brief Summary
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DaTSCAN is an important tool in the diagnosis and clinical management of Parkinson's syndromes. New cadmium-zinc-telluride (CZT) systems allow time and/or dose reduction. This can be interesting in DaTSCAN acquisitions as those are long-lasting, often on difficult patients. This study will evaluate the diagnostic performances of a new 3D-ring CZT camera in DaTSCAN SPECT.

Detailed Description
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DaTSCAN is an important tool in the diagnosis and clinical management of Parkinson's syndromes, particularly for the diagnosis of Parkinson's disease or in the exploration of dementia-type neurodegenerative diseases. The acquisition of tomoscintigraphic images is performed 3 hours after injection and lasts approximately 30 minutes on a conventional gamma camera. Recently, the introduction of systems equipped with cadmium-zinc-telluride (CZT) technology has made it possible to reduce acquisition times and/or injected doses. Among these systems, some new 3D-ring CZT cameras allow tomoscintigraphic acquisitions to be carried out from the outset for the exploration of different organs. Patients included in this study will be double scanned both on a conventional camera and on the new multipurpose CZT system, with CT. The primary objective is to evaluate the diagnostic concordance between the DaTSCAN brain scintigraphy images from the new CZT SPECT/CT system and those from the conventional SPECT camera, when visually interpreted blindly by experienced observers (nuclear medicine physicians), according to a diagnostic scale. Striatal binding ratios (SBR) will also be compared. Time reduction will also be evaluated on DaTSCAN SPECT data from the new multi-purpose CZT system.

Official Title
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Clinical Evaluation of a New Multipurpose Whole-body CZT Camera in DaTSCAN Brain Scintigraphy: a Head-to-head Comparison With a Conventional System.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Additional acquisition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred to our Nuclear Medicine department for DaTSCAN scintigraphy. Exclusion Criteria: Under 18 years-old patients. Pregnant women or at risk of pregnancy. Breast feeding. Painful patients. Patients under guardianship. Patients in whom a standard examination is not feasible (agitation).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will undergo SPECT acquisitions with both new multipurpose CZT camera and conventional SPECT camera.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DaTSCAN brain scan images from the new CZT SPECT system<br>All patients will undergo additional SPECT acquisition (30min added time approximately), with no added radiation, with both new multipurpose CZT camera (StarGuide system, GE Healthcare, Haïfa, Israel) and conventional SPECT camera (Discovery 670, GE Healthcare, Haïfa, Israel) | Other: Additional acquisition<br>* Additional SPECT acquisition (30min added time approximately), with no added radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the visual Benamer Scale between new and conventional SPECT systems | Evaluation will be made by an experienced observer (senior physician of the nuclear medicine department), for images obtained for each of the patients included, according to the Benamer's 5-category scale with 5 categories (normal, reduce type1, reduce type 2, reduce type 3, other reductions) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Striatal Binding ratios (defined as ratio between striatal uptake and background uptake) between new and conventional SPECT systems | SBR obtained with each of the 2 methods, at the end of the optimal image acquisition time and at reduced time. | Day 0 | 
| Evaluation of time reduction. | Visual diagnostic classification of scintigraphic images on the Benamer scale when reducing the acquisition time, for each of the 2 acquisition methods. | Day 0 | 
| Evaluation of time reduction | visual diagnostic classification of scintigraphic images made by an experienced observer (senior physician of the nuclear medicine department), for the images obtained with each of the 2 scintigraphic methods used, for each of the patients included, on the simplified Benamer diagnostic scale with only 2 categories (category 1: normal images / other categories: abnormal images), at the end of the optimal time foreseen for the acquisition of the images as well as at reduced time. | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DaTSCAN, Multipurpose CZT camera