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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
BrightMatter™ Plan (BMP): BMP is a software that enables surgeons to plan their neurosurgery preoperatively. BMP automatically generates whole brain tractography and highly accurate fusion of anatomical MRI and DTI images. BrightMatter™ Bridge (BMB):BMB involves offering SMI's MRI expertise to ensure a smooth workflow in neuroimaging including DTI to ensure optimized protocols are used to acquire the DTI images. Once the images are acquired, they are evaluated for their quality in real time using a quality control (QC) algorithm. The QC allows quality assessment of DTI images at the time-of-scan allowing for immediate correction while the patient is still there and reduces the need for patient re-scan. BrightMatter™ Guide (BMG): BMG is a neuro-navigation system that utilizes the DTI information and the trajectory planned by the surgeon in BMP pre-operatively, but bringing it into the operating room intraoperatively.
Total volume of tract damage
Measure # of damaged tracts
Time frame: Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
Total size of craniotomy (resection zone)
Measure craniotomy size
Time frame: Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
Total time it takes for the surgeon to pre-operatively plan cranial approach.
Measured in hours
Time frame: Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
Total OR time
Measured in hours
Time frame: Assessed during surgical visit
Duration of hospital stay
Measured in # of days
Time frame: Assessed during surgical visit up to 26 weeks
Total cost of surgery
Time frame: Assessed through study completion, an average of 1 year
Quality of life assessment
Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment
Time frame: Assessed during surgical visit up to 26 weeks
Functional testing
Measured using a routine functional impairment test for the pediatric population known as the Lansky performance scale
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Time frame: Assessed during surgical visit up to 26 weeks
# deaths and complications with surgery
Number of cases
Time frame: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).