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Novel Multimodality Imaging for Navigation in Skull Base Surgery (SBN)
Novel Multimodality Imaging Techniques for Neurosurgical Planning and Stereotactic Navigation in Lateral Skull Base Surgery: a Feasibility Study
Successful neurosurgery to remove tumours around the base of the skull, such as a vestibular schwannoma, depends on achieving maximal tumour removal whilst preserving crucial neurological functions such as facial movement, and maintaining quality of life.
Current techniques to direct surgery are based on the surgeon's expertise and knowledge of the relevant anatomy, supplemented by the use of electrical recording and stimulation of the facial nerve. However, it is often very difficult to visualise the nerve during surgery and facial nerve paralysis remains a potentially devastating complication of surgery.
Advanced imaging methods may be used to visualise important neural connections in the brain and computer-assisted processing can generate tumour maps from MRI and ultrasound scans. This study aims to utilise these technologies to develop a 3D navigation system for skull base surgery.
This study aims to develop a system that will combine MRI and intraoperative ultrasound imaging to enhance the surgeon's view of the tumour, facial nerve and other surrounding critical structures during surgery. This information will be made available in the navigation system in the operating room so that operations are more precise resulting in better tumour removal rates and fewer complications.
The system will be assessed during the treatment of 20 patients with vestibular schwannoma at the National Hospital for Neurology and Neurosurgery. This feasibility study will validate the different parts of the new system and help us design a future research study to determine its effectiveness in improving patient care.
This project will result in safer and more effective neurosurgery, with potential consequent financial savings for the NHS and the UK, in addition to marked improvements in the quality of life of patients and reduced dependency upon others.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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London, Verenigd Koninkrijk, WC1E 6BT
- Werving
- University College London/University College London Hospitals Joint Research Office
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Contact:
- Misha Ladva
- Telefoonnummer: 02034475199
- E-mail: randd@ucl.ac.uk
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Adult patients aged 18-85 years
- Patients with a vestibular schwannoma who are scheduled for surgery
- Patients willing and able to provide written informed consent
Exclusion Criteria:
- Patients aged under 18 years of age or older than 85 years
- Previous, treated posterior fossa brain tumour(s)
- Previous ear or facial surgery on ipsilateral side of tumour
- Neurofibromatosis Type II
- Participation in other clinical trials
- Any contraindication for MR imaging
- Any contraindication for MR contrast agent administration
- Any contraindication for CT imaging
- Pregnancy or breast feeding
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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SBN arm
We will evaluate the feasibility of using an integrated navigation system incorporating pre-operative MRI and intraoperative ultrasound images
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Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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To assess the functionality and performance of a 3D surgical technical platform for integrating data from 3 different data sources (MRI, US and Neuronavigation data) in a clinical setting using a composite of quantitative and qualitative measurements
Tijdsspanne: Data will be collected on the date of patients' routine surgical procedure, assessed on 1 day from the start time (hh:hh) of set-up of the 3d surgical platform to the end time (hh:hh) of surgery
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Composite of quantitative and qualitative measurements to assess the system's functionality and technical performance
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Data will be collected on the date of patients' routine surgical procedure, assessed on 1 day from the start time (hh:hh) of set-up of the 3d surgical platform to the end time (hh:hh) of surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Correlation of electromyographic stimulation of facial nerve with preoperatively acquired diffusion imaging
Tijdsspanne: A minimum of 9 time points (selected at random) during each surgical procedure, assessed on 1 day from the start time (hh:hh) to the end time (hh:hh) of surgery
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Stimulation response (binary outcome) and amplitude (mA)
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A minimum of 9 time points (selected at random) during each surgical procedure, assessed on 1 day from the start time (hh:hh) to the end time (hh:hh) of surgery
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Postoperative tumour volume on contrast-enhanced MRI and its correlation with the final intraoperative ultrasound measurement
Tijdsspanne: Final intraoperative US volume vs post op MRI volume (within 3 months)
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Tumour volume (cm3) on MRI and US
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Final intraoperative US volume vs post op MRI volume (within 3 months)
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Average duration of surgical procedure using 3D navigation system
Tijdsspanne: From start time to end time of each surgical procedure, assessed on 1 day
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Time (hours)
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From start time to end time of each surgical procedure, assessed on 1 day
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Documentation of technical system issues and implemented solutions
Tijdsspanne: From start time to end time of each surgical procedure, assessed on 1 day
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Documentation of technical system issues and implemented solutions (using qualitative research methods)
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From start time to end time of each surgical procedure, assessed on 1 day
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Otorinolaryngologische neoplasmata
- KNO-ziekten
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Oor Ziekten
- Neoplasmata van het zenuwstelsel
- Ziekten van de hersenzenuw
- Neuro-endocriene tumoren
- Zenuwschede neoplasmata
- Neoplasmata van het perifere zenuwstelsel
- Craniale zenuwneoplasmata
- Neuroma
- Vestibulocochleaire zenuwaandoeningen
- Retrocochleaire ziekten
- Neurilemmoom
- Neuroma, akoestisch
Andere studie-ID-nummers
- 17/0661
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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