跳至主要内容
临床试验/NCT06976788
NCT06976788招募中不适用

Creation of a Database of Healthy Subjects With 18FDG PET Brain Imaging as Part of the MOBILE Project (Multimodal Whole-Brain Imaging in Epilepsy)

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
cerebral glucose consumption

研究概览

简要总结

The MOBILE project is part of the dynamic European collaboration of the Human Brain Project (HBP). The overall aim of the project is to characterize brain structure and function in healthy subjects and patients with epilepsy, using a quantitative multimodal approach involving both neuroimaging (MRI, PET) and electrophysiology (EEG/MEG). The project is funded by the European HBP consortium, and the data acquired will ultimately be made available to the scientific community formed by this international collaboration. Several aspects of the project have already been initiated on the basis of extensions to previous authorizations, or as part of care activities. As part of this overall project, the present MOBILE-PET application concerns exclusively the performance of 18F-FDG PET (Positron Emission Tomography) imaging in the 30 healthy adult subjects in the protocol (aged 18 to 65, with inclusion parity for gender). This cerebral examination, performed at rest on a 45-minute 3D volume acquisition, enables quantitative measurement of the metabolic consumption of glucose underlying global synaptic activity, and to determine the associated connectivity. Around 1,500 examinations of this type are carried out each year in our department as part of care for patients with brain pathology, and over 10,000 for patients with cancer. This examination requires intravenous injection of a weakly radioactive tracer corresponding to a radiopharmaceutical which has been approved for marketing for over 20 years. We also carried out and finalized a similar project in 2007 on 60 healthy subjects, using a previous-generation PET camera (NCT00484523). The Nuclear Medicine Department holds clinical research authorizations for imaging in patients and healthy subjects (including early phase and first-in-man, although the present project does not fall into this research categarogy).

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •- Female or male, over 18 and under 65 years of age.
  • •Subject free of any general illness, psychiatric disorders or infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology of the central nervous system, as determined on examination,
  • •Subject not receiving chronic treatment, particularly psychotropic,
  • •Subject with no history of alcoholism or drug addiction,
  • •Subject with no contraindications to PET scintigraphic exploration (pregnancy and breast-feeding),
  • •Subject with social security coverage,
  • •Subject having read, understood and signed an informed consent form.

排除标准

  • •- Minors,
  • •Pregnant or breast-feeding women,
  • •Women of childbearing age without contraception,
  • •Subjects presenting a contraindication to PET scintigraphic exploration,
  • •adult subject to a legal protection measure, as provided for in L.1121-6 to L.1121-8 of the French Public Health Code.

研究组 & 干预措施

Whole-Brain Imaging

Other

干预措施: Tomography exam (Other)

结局指标

主要结局

cerebral glucose consumption

时间窗: Baseline and 24 months (longitudinal follow-up)

次要结局

  • Metabolic connectivity(Baseline and 24 months (longitudinal follow-up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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