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DTI & Tractography in Pediatric Tumor Surgery

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ClinicalTrials.gov Identifier: NCT02810626
Recruitment Status : Unknown
Verified June 2016 by Sandrine DeRibaupierre, London Health Sciences Centre.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborators:
University of Western Ontario, Canada
Synaptive Medical
Information provided by (Responsible Party):
Sandrine DeRibaupierre, 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.

Condition or disease Intervention/treatment Phase
Brain Damage, Chronic Cerebellar Cognitive Affective Syndrome Cerebellar Mutism Device: BrightMatter™ products Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
No Intervention: Control
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
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

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.

Other Name: BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Total OR time [ Time Frame: Assessed during surgical visit ]
    Measured in hours

  3. Duration of hospital stay [ Time Frame: Assessed during surgical visit up to 26 weeks ]
    Measured in # of days

  4. Total cost of surgery [ Time Frame: Assessed through study completion, an average of 1 year ]
  5. 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

  6. 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

  7. # deaths and complications with surgery [ Time Frame: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year). ]
    Number of cases



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810626


Contacts
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Contact: Sandrine DeRibaupierre, MD 519-685-8107 sderibau@uwo.ca
Contact: Ali Khan, MD 519-931-5777 ext 24280 alir@robarts.ca

Sponsors and Collaborators
London Health Sciences Centre
University of Western Ontario, Canada
Synaptive Medical
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Responsible Party: Sandrine DeRibaupierre, Neurosurgeon, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02810626    
Other Study ID Numbers: UWO HSREB Ref#107499
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Neoplasms
Brain Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries