DTI & Tractography in Pediatric Tumor Surgery
Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: 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).
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Andet: Interventional
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).
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BrightMatter™ Plan (BMP): BMP er en software, der gør det muligt for kirurger at planlægge deres neurokirurgi præoperativt. BMP genererer automatisk helhjernetraktografi og meget nøjagtig sammensmeltning af anatomiske MR- og DTI-billeder. BrightMatter™ Bridge (BMB): BMB involverer at tilbyde SMI's MRI-ekspertise for at sikre en jævn arbejdsgang inden for neuroimaging inklusive DTI for at sikre, at optimerede protokoller bruges til at erhverve DTI-billederne. Når billederne er erhvervet, evalueres de for deres kvalitet i realtid ved hjælp af en kvalitetskontrol (QC) algoritme. QC tillader kvalitetsvurdering af DTI-billeder på scanningstidspunktet, hvilket giver mulighed for øjeblikkelig korrektion, mens patienten stadig er der, og reducerer behovet for genscanning af patienten. BrightMatter™ Guide (BMG): BMG er et neuro-navigationssystem, der bruger DTI-informationen og den bane, som kirurgen i BMP har planlagt præoperativt, men som bringer den ind på operationsstuen intraoperativt.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Total volume of tract damage
Tidsramme: Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
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Measure # of damaged tracts
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Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
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Total size of craniotomy (resection zone)
Tidsramme: Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
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Measure craniotomy size
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Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Total time it takes for the surgeon to pre-operatively plan cranial approach.
Tidsramme: Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
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Measured in hours
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Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
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Samlet ELLER-tid
Tidsramme: Vurderet under kirurgisk besøg
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Målt i timer
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Vurderet under kirurgisk besøg
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Duration of hospital stay
Tidsramme: Assessed during surgical visit up to 26 weeks
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Measured in # of days
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Assessed during surgical visit up to 26 weeks
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Total cost of surgery
Tidsramme: Assessed through study completion, an average of 1 year
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Assessed through study completion, an average of 1 year
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Quality of life assessment
Tidsramme: Assessed during surgical visit up to 26 weeks
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Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment
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Assessed during surgical visit up to 26 weeks
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Functional testing
Tidsramme: Assessed during surgical visit up to 26 weeks
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Measured using a routine functional impairment test for the pediatric population known as the Lansky performance scale
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Assessed during surgical visit up to 26 weeks
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# deaths and complications with surgery
Tidsramme: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
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Number of cases
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Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UWO HSREB Ref#107499
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