- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128345
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Suzanne Emerton
- Phone Number: 00 44 20 3447 7428
- Email: semerton@nhs.net
Study Locations
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London, United Kingdom, WC1E 6BT
- Recruiting
- University College London/University College London Hospitals Joint Research Office
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Contact:
- Misha Ladva
- Phone Number: 02034475199
- Email: randd@ucl.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of electromyographic stimulation of facial nerve with preoperatively acquired diffusion imaging
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Otorhinolaryngologic Neoplasms
- Otorhinolaryngologic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Ear Diseases
- Nervous System Neoplasms
- Cranial Nerve Diseases
- Neuroendocrine Tumors
- Nerve Sheath Neoplasms
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Neuroma
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Neurilemmoma
- Neuroma, Acoustic
Other Study ID Numbers
- 17/0661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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