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临床试验/NCT00484523
NCT00484523已完成早期 1 期

Constitution of a Standardized Neural Imaging Database in Healthy Subjects

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年7月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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