An interventional study of BrightMatter™ products in Brain Damage, Chronic, Cerebellar Cognitive Affective Syndrome and Cerebellar Mutism, sponsored by London Health Sciences Centre. Status unknown. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2016-06-23.
Sponsored by London Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →London Health Sciences Centre is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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).
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.
Also known as: BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide
Total volume of tract damage
Measure # of damaged tracts
Time frame: 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
Time frame: Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
Total time it takes for the surgeon to pre-operatively plan cranial approach.
Measured in hours
Time frame: Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
Total OR time
Measured in hours
Time frame: Assessed during surgical visit
Duration of hospital stay
Measured in # of days
Time frame: Assessed during surgical visit up to 26 weeks
Total cost of surgery
Time frame: Assessed through study completion, an average of 1 year
Quality of life assessment
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
Functional testing
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
# deaths and complications with surgery
Number of cases
Time frame: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
No study locations are listed for this record.
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre