跳至主要内容
临床试验/NCT03100227
NCT03100227已完成不适用

(18)F-FDG PET Database of Adult Healthy Individuals for Clinical Studies in Epileptic Patients

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.

研究概览

简要总结

Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide.

Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Focal Hypometabolism on interictal [18F]-FDG PET is a hallmark of the Seizure Onset Zone as well as surrounding areas. Using [18F]-FDG PET is thus particularly useful to determine the seizure onset zone of epileptic patients and thus to guide surgical treatment when antiepileptic drugs fail.

Interpretation of PET images primarily relies on standard visual analysis, but statistical analysis, with the widely used Statistical Parametric Mapping (SPM) software improves the diagnostic yield of PET. Over the past years, some authors have thus reported that the use of SPM can result in greater sensitivity and specificity of PET imaging in patients with partial epilepsy.

In order to perform statistical analysis of PET images to compare brain metabolism of epileptic patients and healthy controls, it is necessary to collect a normative database of [18F]-FDG PET images in healthy controls.

The purpose of this study is (i) collect a normative database of [18F]-FDG PET images in healthy adults controls to evaluate rigorously the diagnostic value of multimodal imaging for non-invasive localization of the EZ and (ii) to evaluate the test-retest reliability of [18F]-FDG PET scanning.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy adult controls
  • Age 20-65 years
  • Signed informed consent form.

排除标准

  • Contraindication to the MRI
  • Known neurological disease
  • Adult subject to legal protection measure.
  • Women of childbearing age who do not have effective contraception

结局指标

主要结局

Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.

时间窗: Day 1

40 healthy controls (age range 20-65 years) will undergo \[18F\]-FDG PET. The Glucose Metabolism for whole brain will be determined with \[18F\]-FDG PET for each subject.

次要结局

  • Test-reliability(Week 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验