DTI & Tractography in Pediatric Tumor Surgery

Brain Damage, Chronic Clinical Trial

Official title:

Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02810626
• Other study ID #: UWO HSREB Ref#107499
• Status: Not yet recruiting
• Phase: N/A
• First received: March 18, 2016
• Last updated: June 20, 2016
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: June 2016
• Source: London Health Sciences Centre
• Contact: Sandrine DeRibaupierre, MD
• Phone: 519-685-8107
• Email: sderibau[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Damage, Chronic
• Brain Injuries
• Cerebellar Cognitive Affective Syndrome
• Cerebellar Mutism

Intervention

Device:
• BrightMatter™ products
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
London Health Sciences Centre	Synaptive Medical, University of Western Ontario, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Primary	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).	No
Secondary	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).	No
Secondary	Total OR time	Measured in hours	Assessed during surgical visit	No
Secondary	Duration of hospital stay	Measured in # of days	Assessed during surgical visit up to 26 weeks	No
Secondary	Total cost of surgery		Assessed through study completion, an average of 1 year	No
Secondary	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	No
Secondary	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	No
Secondary	# deaths and complications with surgery	Number of cases	Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).	No