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.)
研究组 & 干预措施
Control
Control Group (surgical standard of care): Subjects 18 years and younger diagnosed with a pediatric brain tumor, and who are eligible for surgical treatment will be recruited. All subjects will have clinical MRI scans that include a diffusion tensor imaging (DTI) protocol. Surgery will be carried out according to usual standard of care, without the use of processing for DTI tractography. Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months. Pre-operative and post-operative quality of life assessments, functional testing and clinical outcome tests will be conducted at this post-operative period (6-months).
Interventional
Interventional Group (involvement of all BrightMatter™ products): Subjects 18 years and younger diagnosed with a pediatric brain tumor and who are eligible for surgical treatment will be recruited. All subjects will have clinical MRI scans that include a diffusion tensor imaging (DTI) protocol and will be sent to the interventional technology (BrightMatter Bridge) for quality control. The QC'ed images will then be sent to a pre-operating planning software (BrightMatter Plan) for planning the surgical approach. Surgery will be carried out with guidance from the exported plan and the intra-operative neuro-navigation software, BrightMatter Guide, with the use of post-processing DTI tractography. Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months. Pre-operative and post-operative quality of life assessments, functional testing and clinical outcome tests will be conducted at this post-operative period (6-months).
干预措施: BrightMatter™ products (Device)
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
- Total OR time(Assessed during surgical visit)
- 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)
- 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