Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- PET11C-Fe_CIT method for the staging of patients with Parkinson.
研究概览
简要总结
The role of PET for the in vivo study of the presynaptic dopaminergic system with 11C-Fe-CIT is universally recognized, and its use has also become routine in numerous nuclear medicine centers in Europe. The indication for the examination is provided exclusively by the clinic in the presence of extrapyramidal signs in the suspicion of Parkinson's disease (PD) or for the differential diagnosis of parkinsonisms. The existence of factors that influence the prognosis of patients with PD or parkinsonism associated with other degenerative diseases is known.
Given these premises, the possibility of identifying the disease in the early stages appears fundamental.
For this purpose the following should be considered:
- an automatic analysis method based on the measurement of radiotracer uptake at the level of individual voxels, following Statistical Parametric Mapping procedures.
- the analysis based on regions of interest (ROIs) positioned ad hoc by the operator which will give the value of the ROI to reference region ratio. In particular, ROIs on the basal ganglia (caudate, putamen) towards cerebellum.
Both of these methods offer a quantitative measurement of the damage at the level of the structures involved that is absolutely better than the visual investigation of the distribution of radioactivity in the central nervous system.
In this study the investigators want to compare results provided by methods 1 and 2 in the populations under examination to evaluate the data relating to the specificity and sensitivity of the test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed with initial PD or parkinsonism;
- •signature of informed consent.
排除标准
- •patients < 18 years
结局指标
主要结局
PET11C-Fe_CIT method for the staging of patients with Parkinson.
时间窗: 2 years
All patients undergo to 11C Fe CIT PET examination and the data will be analyzed with ROI and SPM voxel based and correlated with neurological data.
次要结局
未报告次要终点
研究者
Chiti Arturo
Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele
IRCCS San Raffaele
