Intraoperative Use of a MR Tomography System Combined With Neuronavigation - Analysis of the Craniopharyngioma Subgroup ("Intraoperative Nutzung Eines Kernspintomographie-Systems in Direkter Kopplung Mit Einem Neuronavigations-System")
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Rate of additional tumor removal
研究概览
简要总结
Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.
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
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complex craniopharyngioma > 1cm extension within 2 or more cranial fossae or ventricular system
- •Patient or legal representative able to provide written informed consent
排除标准
- •tumor size< 1 cm
- •Patients with any condition considered a contraindication to MRI
- •Patients with any condition considered a contraindication for surgery
- •Hypothalamic disturbances
- •Hypothalamic edema
结局指标
主要结局
Rate of additional tumor removal
时间窗: up to 3-4 months following surgery
Number of patients in whom non suspected tumor remants were indicated by intraoperative MRI and remnants could be removed completely thereafter. Results have to be confirmed in 1st follow up imaging.
Rate of achievement of intended extent of removal
时间窗: up to three months following surgery
It is examined whether the extent of tumor removal defined prior to surgery was achieved
Diagnostic reliability
时间窗: within 3 -4 months following surgery
false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery
次要结局
- Surgical complication(within 1st week following surgery)