Novel Multimodality Imaging for Navigation in Skull Base Surgery
NCT ID: NCT04128345
Last Updated: 2019-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2019-05-01
2021-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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
Use of navigation system
Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound
Interventions
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Use of navigation system
Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound
Eligibility Criteria
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Inclusion Criteria
* Patients with a vestibular schwannoma who are scheduled for surgery
* Patients willing and able to provide written informed consent
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
University College, London
OTHER
Responsible Party
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Locations
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University College London/University College London Hospitals Joint Research Office
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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17/0661
Identifier Type: -
Identifier Source: org_study_id
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