Clinical trial NCT02810626: DTI & Tractography in Pediatric Tumor Surgery
Official title: Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Damage, Chronic
Cerebellar Cognitive Affective Syndrome
Cerebellar Mutism
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
name: Synaptive Medical
First posted: 2016-06-23
Enrollment: 24
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Total volume of tract damage
timeFrame: Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
measure: Total size of craniotomy (resection zone)
timeFrame: Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
Secondary outcomes:
measure: Total time it takes for the surgeon to pre-operatively plan cranial approach.
timeFrame: Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
measure: Total OR time
timeFrame: Assessed during surgical visit
measure: Duration of hospital stay
timeFrame: Assessed during surgical visit up to 26 weeks
measure: Total cost of surgery
timeFrame: Assessed through study completion, an average of 1 year
measure: Quality of life assessment
timeFrame: Assessed during surgical visit up to 26 weeks
measure: Functional testing
timeFrame: Assessed during surgical visit up to 26 weeks
measure: # deaths and complications with surgery
timeFrame: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
Other outcomes:
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