Brain Damage, ChronicNCT02810626
DTI & Tractography in Pediatric Tumor Surgery
A study testing BrightMatter™ products in people with Brain Damage, Chronic and Cerebellar Cognitive Affective Syndrome, run by London Health Sciences Centre.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Brain Damage, Chronic, Cerebellar Cognitive Affective Syndrome, Cerebellar Mutism
- What is being tested?
- BrightMatter™ products
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric subjects between the ages of 0-18 years with a brain tumor.
Who cannot join
- Pediatric subjects with contra-indication to MRI (metal, claustrophobia, etc.)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
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.
Read the 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.
- Being tested
- BrightMatter™ products
- Medical subject headings
- Brain Damage, Chronic, Cerebellar Cognitive Affective Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrightMatter™ productsDevice
Also called BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | Other | 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). Receives: Device: BrightMatter™ products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of tract damage
Measure # of damaged tracts
Measured: 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
Measured: Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
Secondary outcomes (7)
Total time it takes for the surgeon to pre-operatively plan cranial approach.
Measured in hours
Measured: 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
Measured: Assessed during surgical visit
Duration of hospital stay
Measured in # of days
Measured: Assessed during surgical visit up to 26 weeks
Total cost of surgery
Measured: 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
Measured: 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
Measured: Assessed during surgical visit up to 26 weeks
# deaths and complications with surgery
Number of cases
Measured: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Damage, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, Synaptive Medical
- Responsible party
- Principal investigator, Sandrine DeRibaupierre, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810626
- Sponsor's protocol ID
- UWO HSREB Ref#107499
- Status last verified
- Jun 2016
- First submitted
- 18 Mar 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
- ClinicalTrials.gov ID
- NCT02810626
- Acronym / sponsor ID
- UWO HSREB Ref#107499
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, Synaptive Medical
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Other | Device: BrightMatter™ productsInterventional 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). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric subjects between the ages of 0-18 years with a brain tumor.
Key exclusion criteria (1 listed)
- Pediatric subjects with contra-indication to MRI (metal, claustrophobia, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrightMatter™ productsAlso: BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ GuideBrightMatter™ 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. | Device | Interventional |
Primary outcome
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
7 secondary outcomes
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).
Total OR time
Time frame: Assessed during surgical visit
Duration of hospital stay
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
Time frame: Assessed during surgical visit up to 26 weeks
Functional testing
Time frame: Assessed during surgical visit up to 26 weeks
# deaths and complications with surgery
Time frame: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing BrightMatter™ products in people with Brain Damage, Chronic and Cerebellar Cognitive Affective Syndrome, run by London Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine DeRibaupierre, MD (519-685-8107, sderibau@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of tract damage (time frame: Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.