跳至主要内容
临床试验/NCT03525080
NCT03525080已完成不适用

Diagnostic Assessment Study, Single Site and Prospective, comparing18F-DOPA PET and Multiparametric RMI in Initial Exploration of Diffuse Glial Tumors

Center Eugene Marquis2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年6月12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
16
试验地点
2
主要终点
PET pictures and MRI sequences comparison

研究概览

简要总结

For patient having a brain tumor, RMI is the standard exam for tumor characterization and determines initial surgery.

The aim of this study is to assess if PET could provide additional information that could have an impact on surgery (indication and planification)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Suspected glial resectable tumor
  • Free and informed consent
  • Affiliated to French social security

排除标准

  • Suspected high grade glioma
  • Surgical emergency
  • Pregnant or breastfeeding woman
  • Patient deprived of their liberty or under guardianship
  • Patient not able to follow study medical monitoring for geographical, social or psychological reasons
  • Treated with carbidopa, catechol-O-methyl transferase inhibitor, haloperidol, reserpine within 2 weeks before PET imagery

结局指标

主要结局

PET pictures and MRI sequences comparison

时间窗: Imagings performed up to 29 days after inclusion (before brain surgery)

Comparison of PET pictures and MRI sequences will be done in order to assess concordance between both imagings

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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