Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Response to electrical stimulation
研究概览
简要总结
The objective of this study is to evaluate to what extent the capacity of the NODDI model can allow, in case of Malignant brain tumor patients with vasogenic edema, the elaboration of a reliable cerebral functional mapping in accordance with the data of direct electrical stimulation (DES) which is today the reference tool.
the patient's participation in this study implies an additional visit during which an MRI examination without injection of contrast medium will be performed, lasting approximately 40 minutes (including installation and de-installation).
详细描述
This is a single-center, prospective, open-label study of neurosurgical patients.
Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without injection of contrast product will be performed, lasting approximately 40 minutes (including installation and de-installation).
The operative time, surgical procedures and postoperative follow-up are not modified in this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient 18 years of age or older,
- •Patient who has read and signed the consent form for participation in the study
- •Patient requiring surgery for a malignant brain tumor with vasogenic edema
- •Patient with an estimated life expectancy of more than 3 months.
排除标准
- •Patient under legal protection, guardianship or trusteeship
- •Patient not affiliated to the French social security system
- •Contraindication to MRI (patient with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patient with hemostatic clips on intracerebral aneurysms or with orthopedic implants, claustrophobic patient)
- •Psychiatric history
- •Refusal to be informed of an abnormality detected during the MRI
- •Pregnant or breastfeeding woman
结局指标
主要结局
Response to electrical stimulation
时间窗: Hour 24
Response to electrical stimulation, which determines the presence or absence of an essential bundle, is the primary end point. The ability of the NODDI-tract method to reconstruct essential bundles in vasogenic edema will be assessed by estimating the correspondence between the response to intraoperative direct electrical stimulation (DES) and the presence of an MRI reconstructed bundle. Based on the response to electrical stimulation, the NODDI-tract data will be classified into one of four groups: * True positive = response to stimulation and presence of an MRI beam * True negative = no response to stimulation and no beam on MRI * False positive = no response to stimulation and presence of a beam on MRI * False-negative = response to stimulation and absence of beam in MRI. The distance between the reconstructed beam and the stimulation point (whether or not the stimulation was effective) will also be measured.
次要结局
- Average distance to a reference atlas(Hour 24)
- Number of reconstructed fibers(Hour 24)