Clinical Trial: DTI & Tractography in Pediatric Tumor Surgery

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: London Health Sciences Centre

Current Primary Outcome:

• Total volume of tract damage [ Time Frame: Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year). ]
  Measure # of damaged tracts
• Total size of craniotomy (resection zone) [ Time Frame: Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject). ]
  Measure craniotomy size

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Total time it takes for the surgeon to pre-operatively plan cranial approach. [ Time Frame: Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject). ]
  Measured in hours
• Total OR time [ Time Frame: Assessed during surgical visit ]
  Measured in hours
• Duration of hospital stay [ Time Frame: Assessed during surgical visit up to 26 weeks ]
  Measured in # of days
• Total cost of surgery [ Time Frame: Assessed through study completion, an average of 1 year ]
• Quality of life assessment [ Time Frame: Assessed during surgical visit up to 26 weeks ]
  Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment
• Functional testing [ Time Frame: Assessed during surgical visit up to 26 weeks ]
  Measured using a routine functional impairment test for the pediatric population known as the Lansky performance scale
• # deaths and complications with surgery [ Time Frame: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year). ]
  Number of cases

Original Secondary Outcome: Same as current

Information By: London Health Sciences Centre

Dates:
Date Received: March 18, 2016
Date Started: July 2016
Date Completion: July 2017
Last Updated: June 20, 2016
Last Verified: June 2016