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
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
- 否
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
研究点 (2)
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