Constitution of a Standardized Neural Imaging Database in Healthy Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- precise brain morphology
研究概览
简要总结
MRI is a powerful imaging tool used for the precise study of brain morphology (morphometric study, tissue study, study of connectivity).
Isotopic examinations by Single Photon Emission Tomography (SPET) and Positron Emission Tomography (PET) are used to explore cerebral perfusion metabolism (99mTc- ECD SPET and 18FDG PET), as well as dopaminergic neurotransmission (123I FP-CIT SPET, DATSCAN®).
These examinations routinely contribute to the clinical diagnosis and surveillance of many neurological pathologies (dementias, Parkinson syndromes, epilepsies, concussions, vascular pathology, brain tumors, etc.).
As a result of the original morphological and functional information they provide, these examinations are being increasingly included in clinical research protocols involving the brain.
The absolute or relative quantification of anomalies observed, however, can be obtained only after comparison to a database of normal subjects.
The creation of these databases is currently limited by their cost and strictly single center nature (physical characteristics of each center's MRI, gamma cameras and PET scanner).
The aim of this multidisciplinary study is to constitute a standardized database of multimode neural imaging (SPET, PET and MRI) to be able to objectively quantify anomalies observed in patients, at the scale of a group or an individual, for the diagnosis and surveillance of neurological diseases.
Participants will be paid €350. 60 healthy subjects between 20 and 80 years of age (30 men and 30 women) will be recruited over 3 years. 4 examinations will be programmed over 2 days (one cerebral MRI, on 18FDG PET, one 99mTc-ECD SPET and one DATSCAN®).
The strictly single center character of this study is explained by the variability of the physical characteristics of the imaging equipment used (MRI, SPET and PET scan) inherent to each center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no neurological or psychiatric history
- •no serious disease
- •receiving no neurotropic
- •no alcoholism
- •no drug addiction
- •social security cover
- •written informed consent
排除标准
- •pregnancy
- •breast feeding
- •contraindication to MRI, SPET or PET exploration
结局指标
主要结局
precise brain morphology
时间窗: two days
次要结局
未报告次要终点
