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DTI & Tractography in Pediatric Tumor Surgery

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BrightMatter™ products
Sponsored by
London Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Damage, Chronic

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    Control

    Interventional

    Arm Description

    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 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).

    Outcomes

    Primary Outcome Measures

    Total volume of tract damage
    Measure # of damaged tracts
    Total size of craniotomy (resection zone)
    Measure craniotomy size

    Secondary Outcome Measures

    Total time it takes for the surgeon to pre-operatively plan cranial approach.
    Measured in hours
    Total OR time
    Measured in hours
    Duration of hospital stay
    Measured in # of days
    Total cost of surgery
    Quality of life assessment
    Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment
    Functional testing
    Measured using a routine functional impairment test for the pediatric population known as the Lansky performance scale
    # deaths and complications with surgery
    Number of cases

    Full Information

    First Posted
    March 18, 2016
    Last Updated
    June 20, 2016
    Sponsor
    London Health Sciences Centre
    Collaborators
    University of Western Ontario, Canada, Synaptive Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02810626
    Brief Title
    DTI & Tractography in Pediatric Tumor Surgery
    Official Title
    Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    London Health Sciences Centre
    Collaborators
    University of Western Ontario, Canada, Synaptive Medical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Damage, Chronic, Cerebellar Cognitive Affective Syndrome, Cerebellar Mutism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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).
    Arm Title
    Interventional
    Arm Type
    Other
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    BrightMatter™ products
    Other Intervention Name(s)
    BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Total volume of tract damage
    Description
    Measure # of damaged tracts
    Time Frame
    Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
    Title
    Total size of craniotomy (resection zone)
    Description
    Measure craniotomy size
    Time Frame
    Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
    Secondary Outcome Measure Information:
    Title
    Total time it takes for the surgeon to pre-operatively plan cranial approach.
    Description
    Measured in hours
    Time Frame
    Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
    Title
    Total OR time
    Description
    Measured in hours
    Time Frame
    Assessed during surgical visit
    Title
    Duration of hospital stay
    Description
    Measured in # of days
    Time Frame
    Assessed during surgical visit up to 26 weeks
    Title
    Total cost of surgery
    Time Frame
    Assessed through study completion, an average of 1 year
    Title
    Quality of life assessment
    Description
    Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment
    Time Frame
    Assessed during surgical visit up to 26 weeks
    Title
    Functional testing
    Description
    Measured using a routine functional impairment test for the pediatric population known as the Lansky performance scale
    Time Frame
    Assessed during surgical visit up to 26 weeks
    Title
    # deaths and complications with surgery
    Description
    Number of cases
    Time Frame
    Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandrine DeRibaupierre, MD
    Phone
    519-685-8107
    Email
    sderibau@uwo.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ali Khan, MD
    Phone
    519-931-5777
    Ext
    24280
    Email
    alir@robarts.ca

    12. IPD Sharing Statement

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    DTI & Tractography in Pediatric Tumor Surgery

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