DTI & Tractography in Pediatric Tumor Surgery

Not Applicable

• Conditions: Brain Damage, Chronic; Cerebellar Cognitive Affective Syndrome; Cerebellar Mutism

• Registration Number: NCT02810626
• Lead Sponsor: London Health Sciences Centre

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.

Study Timeline

• Study First Submitted: 2016-03-18
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-20
• Last Update Submitted: 2016-06-20
• Study First Posted: 2016-06-23
• Last Update Posted: 2016-06-23
• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total size of craniotomy (resection zone)	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	Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).	Measure # of damaged tracts

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	Assessed during surgical visit up to 26 weeks	Measured in # of days
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).	Measured in hours
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	Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment
Total OR time	Assessed during surgical visit	Measured in hours
Functional testing	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	Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).	Number of cases