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DTI & Tractography in Pediatric Tumor Surgery

NCT02810626 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-06-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Western Ontario, Canada

    collaborator OTHER

  • Synaptive Medical

    collaborator INDUSTRY

  • London Health Sciences Centre

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810626 on ClinicalTrials.gov