Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 主要终点
- Total size of craniotomy (resection zone)
研究概览
简要总结
The goal of this project will be to demonstrate that Synaptive Medical's Diffusion Tensor Imaging(DTI) product functionality used in pre-operative planning and intraoperative surgical navigation, improves clinical outcomes corresponding to a reduction in neurological and neuropsychological deficits in pediatric brain tumor surgery.
详细描述
Brain tumours are the most common form of solid tumours in children which often arise from the cerebellum. Treatment involves a complete resection of the tumour. Although surgical resection may eliminate most of the malignancy, signs of post-neurologic deficit may present as a consequence to the treatment.
One such example is cerebellar mutism syndrome (CMS), a postoperative syndrome typically arising 1 to 2 days after resection of a midline posterior fossa tumor; it consists of diminished speech progressing to mutism, emotional lability, hypotonia, and ataxia. While some of the symptoms recover after a few months, neuropsychological testing shows long term deficits in language (agramatism), executive function and verbal memory.
This study aims to investigate whether the use of Synaptive Medical's BrightMatter™ technology can help neurosurgeons better visualize and plan surgeries by avoiding eloquent fiber tracts in the brain and cerebellum; thus minimizing damage pertaining to neurologic and motor functionality. The use of these products will also be assessed for improved clinical outcomes in pediatric tumor surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subjects between the ages of 0-18 years with a brain tumor.
排除标准
- •Pediatric subjects with contra-indication to MRI (metal, claustrophobia, etc.)
结局指标
主要结局
Total size of craniotomy (resection zone)
时间窗: Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
Measure craniotomy size
Total volume of tract damage
时间窗: Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
Measure # of damaged tracts
次要结局
- Duration of hospital stay(Assessed during surgical visit up to 26 weeks)
- Total time it takes for the surgeon to pre-operatively plan cranial approach.(Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).)
- Total cost of surgery(Assessed through study completion, an average of 1 year)
- Quality of life assessment(Assessed during surgical visit up to 26 weeks)
- Total OR time(Assessed during surgical visit)
- Functional testing(Assessed during surgical visit up to 26 weeks)
- # deaths and complications with surgery(Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).)
研究者
Sandrine DeRibaupierre
Neurosurgeon
London Health Sciences Centre