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临床试验/NCT04163276
NCT04163276已完成不适用

Creation of a Database of PET Digital Brain Exams, Adapted to a Population Aged 50 Years and Over, to Help in the Interpretation of Fluoro Desoxy Glucose (FDG) Labelled With Fluor 18 (18F-FDG) PET/CT (Computer Tomography) Exam

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
data base analysis

研究概览

简要总结

This study evaluate the interest to create a new database of PET digital brain exams in population of 50 years and over of patients. Half of patients with no abnormal brain metabolism while the other half patients with Alzheimer's disease.

详细描述

The 18F-FDG cerebral PET can be performed for the detection of neurodegenerative diseases found hypometabolism in the areas concerned (Alzheimer's disease, fronto-temporal dementia, dementia Lewy body etc). The diagnosis is given by the clinician with a visual analysis of the data. Technical aids are now recommended (European recommendations) to complete the diagnosis with a quantitative analysis of different brain regions to a healthy brain base, to guide the diagnosis, in addition to visual analysis.

The emergence of a new technology has allowed the transition from analog PET / CT to digital PET / CT improving spatial resolution and image contrast. Unlike analog PET / CT that uses photomultipliers to detect light, digital PET / CT uses the digital photon counting technique to directly convert light into a digital signal and each crystal is connected to a single detector.

Different software, used in clinical routine, gives access to a quantified analysis of different areas of the brain. However, these programs have been made with healthy subjects of reduced strength (for example, the Neuro Q ® software database is based on 29 healthy patients), with no specific age and thanks to analog PET / CT ( old generation). There is therefore a low specificity in terms of detection of degenerative pathologies, this being explained by a decrease in cerebral metabolism with age 9, mainly at the level of the anterior areas 10 (frontal lobe, temporopolar areas, insular areas, cortex anterior cingulate).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having performed a 18F-FDG cerebral PET/CT exam as part of an Alzheimer's assessment at the Nuclear Medicine department of NANCY, sent by the Geriatric Department
  • Patient who has received complete information on the organization of the research and who has not objected to the exploitation of this data
  • Patient affiliated to a social security

排除标准

  • patient who has received complete information on the organization of the research and who has objected to the exploitation of this data
  • For patients with no abnormality in 18F-FDG PET, Mini Mental State Examination (MMSE) <25 or clinically diagnosed neurodegenerative pathology
  • For patients with typical hypometabolism of 18F-FDG PET/CT, biology of cerebrospinal fluid not in favor of Alzheimer's disease

结局指标

主要结局

data base analysis

时间窗: 1 hour

Comparison of Z-scores from PET/CT of the quantitative analysis of patients without abnormality of the brain metabolism and of typical Alzheimer patients (brain metabolism of the regions involved in Alzheimer's disease), calculated with 2 databases: * An analogue database consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over; * A digital database, consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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