DTI & Tractography in Pediatric Tumor Surgery
Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: 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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Sonstiges: 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 ist eine Software, mit der Chirurgen ihre Neurochirurgie präoperativ planen können. BMP erstellt automatisch eine Ganzhirn-Traktographie und eine hochpräzise Fusion anatomischer MRT- und DTI-Bilder. BrightMatter™ Bridge (BMB): BMB beinhaltet das Angebot der MRT-Expertise von SMI, um einen reibungslosen Arbeitsablauf in der Neurobildgebung einschließlich DTI sicherzustellen, um sicherzustellen, dass optimierte Protokolle zur Erfassung der DTI-Bilder verwendet werden. Sobald die Bilder erfasst sind, werden sie mit einem Qualitätskontrollalgorithmus (QC) in Echtzeit auf ihre Qualität bewertet. Die Qualitätskontrolle ermöglicht die Qualitätsbeurteilung von DTI-Bildern zum Zeitpunkt des Scans, was eine sofortige Korrektur ermöglicht, während der Patient noch da ist, und reduziert die Notwendigkeit eines erneuten Scans des Patienten. BrightMatter™ Guide (BMG): BMG ist ein Neuronavigationssystem, das die DTI-Informationen und die vom Chirurgen in BMP geplante Trajektorie präoperativ nutzt, aber intraoperativ in den Operationssaal bringt.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Total volume of tract damage
Zeitfenster: 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)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Total time it takes for the surgeon to pre-operatively plan cranial approach.
Zeitfenster: 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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Gesamte OP-Zeit
Zeitfenster: Beurteilt während des chirurgischen Besuchs
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Gemessen in Stunden
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Beurteilt während des chirurgischen Besuchs
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Duration of hospital stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UWO HSREB Ref#107499
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