Clinical Evaluation of a New Multipurpose Whole-body CZT Camera in DaTSCAN Brain Scintigraphy: a Head-to-head Comparison With a Conventional System.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in the visual Benamer Scale between new and conventional SPECT systems
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to our Nuclear Medicine department for DaTSCAN scintigraphy.
排除标准
- •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).
研究组 & 干预措施
DaTSCAN brain scan images from the new CZT SPECT system
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)
干预措施: Additional acquisition (Other)
结局指标
主要结局
Change in the visual Benamer Scale between new and conventional SPECT systems
时间窗: Day 0
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)
次要结局
- Evaluation of time reduction(Day 0)
- Change in the Striatal Binding ratios (defined as ratio between striatal uptake and background uptake) between new and conventional SPECT systems(Day 0)
- Evaluation of time reduction.(Day 0)