DTI & Tractography in Pediatric Tumor Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery

Conditions
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Brain Damage, Chronic, Cerebellar Cognitive Affective Syndrome, Cerebellar Mutism

Intervention / Treatment
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* Device: BrightMatter™ products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric subjects between the ages of 0-18 years with a brain tumor. Exclusion Criteria: Pediatric subjects with contra-indication to MRI (metal, claustrophobia, etc.)

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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). | |
| Other: Interventional<br>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). | Device: BrightMatter™ products<br>* 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.<br>* Other names: BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of tract damage | Measure # of damaged tracts | 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 | Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time it takes for the surgeon to pre-operatively plan cranial approach. | Measured in hours | 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 | Assessed during surgical visit | 
| Duration of hospital stay | Measured in # of days | Assessed during surgical visit up to 26 weeks | 
| Total cost of surgery |  | 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 | 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 | Assessed during surgical visit up to 26 weeks | 
| # deaths and complications with surgery | Number of cases | Assessed post-operatively after each surgery. Patient is followed until study completion (  1 year). |