DTI & Tractography in Pediatric Tumor Surgery

NCT02810626 | Unknown

• 1 other identifier: UWO HSREB Ref#107499
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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).

• Total OR time

  Assessed during surgical visit

• Duration of hospital stay

  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

  Assessed during surgical visit up to 26 weeks

Study Arms (2)

Control

NO INTERVENTION

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).

Interventional

OTHER

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

Interventions

BrightMatter™ products DEVICE

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.

Also known as: BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide

Interventional

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric subjects between the ages of 0-18 years with a brain tumor.

You may not qualify if:

• Pediatric subjects with contra-indication to MRI (metal, claustrophobia, etc.)

Sponsors & Collaborators

• London Health Sciences Centre: lead
• University of Western Ontario, Canada: collaborator
• Synaptive Medical: collaborator

MeSH Terms

Conditions

Brain Damage, Chronic; Cerebellar Cognitive Affective Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebellar Diseases

Central Study Contacts

Sandrine DeRibaupierre, MD

CONTACT

519-685-8107; sderibau@uwo.ca

Ali Khan, MD

CONTACT

519-931-5777; alir@robarts.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: June 23, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 23, 2016

Record last verified: 2016-06