Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations: Study of Principal Inter-individual Variation Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mini-mental state score
研究概览
简要总结
The purpose of this study is to define a reference population for FDG-PET neurological examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma (tumor in remission, low disabling chronic tumor).
详细描述
This study will also check normality of cerebral functions in this population and analyse the influence of various variation factors, such as age, sex ratio, education level, professional activity and neuropsychological test results on normal data.
This database could be later used as comparison to patient images defining the gravity and localization of their cerebral functional disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with tumor in remission or low disabling chronic tumor
- •No parenteral chemotherapy for at least 1 month
- •No glucocorticoid treatment
- •No general health modification (asthenia, anorexia, weight reduction)
排除标准
- •Patient having a known neurodegenerative disorder, a general disease or physical problems that can interfere with cognitive function
- •Patient with cerebral pathology history (epilepsy, vascular event, cerebral vascular malformation, tumor, severe cranial trauma, meningitis or infectious or inflammatory encephalitis, hydrocephalus, mental retardation...)
- •Patient not having at least 4 years of education
- •Patient having an anxiolytic or anti-depressive treatment
- •Patient refusing to participate to the study
- •Patient incapable to give informed consent (guardianship)
研究组 & 干预措施
FDG-PET
干预措施: FDG-PET (Device)
结局指标
主要结局
Mini-mental state score
时间窗: Day 0
Montgomery-Åsberg depression rating scale
时间窗: Day 0
Absence of cerebral abnormalities detected with X ray spiral CT
时间窗: Day 0
Absence of neurological impairment detected during standard neurological examination
时间窗: Day 0
Frontal Assessment Battery score
时间窗: Day 0
Mini International Neuropsychiatric Interview (DSM-IV) score
时间窗: Day 0
Absence of cerebral abnormalities detected with PET
时间窗: Day 0
次要结局
- Instrumental Activities of Daily Living evaluation(Day 0)
- Cerebral FDG distribution(Day 0)
- FDG mean activity in cerebral sections(Day 0)