Clinical trial · Interventional
DTI & Tractography in Pediatric Tumor Surgery
Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
NCT02810626CI-TRIAL-00022691unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Damage, Chronic | — | UNRESOLVED | — |
| Cerebellar Cognitive Affective Syndrome | — | UNRESOLVED | — |
| Cerebellar Mutism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BrightMatter™ products | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- 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).
- type
- OTHER
- label
- Interventional
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available
No reference posted for this study.