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
|Condition or disease||Intervention/treatment||Phase|
|Brain Damage, Chronic Cerebellar Cognitive Affective Syndrome Cerebellar Mutism||Device: BrightMatter™ products||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 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
- 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
- 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
- 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
- Total OR time [ Time Frame: Assessed during surgical visit ]Measured in hours
- Duration of hospital stay [ Time Frame: Assessed during surgical visit up to 26 weeks ]Measured in # of days
- Total cost of surgery [ Time Frame: Assessed through study completion, an average of 1 year ]
- 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
- 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
- # deaths and complications with surgery [ Time Frame: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year). ]Number of cases
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
|Contact: Sandrine DeRibaupierre, MDemail@example.com|
|Contact: Ali Khan, MD||519-931-5777 ext firstname.lastname@example.org|