Vestibular SchwannomaSBNNCT04128345
Novel Multimodality Imaging for Navigation in Skull Base Surgery
An observational study of Vestibular Schwannoma, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- Use of navigation system
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 - 85 years with a vestibular schwannoma who are scheduled for surgery and able to provide written informed consent.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Any contraindication for MR contrast agent administration
- Any contraindication for CT imaging
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London/University College London Hospitals Joint Research Office
London, WC1E 6BT
Misha Ladva, 02034475199, randd@ucl.ac.uk
About this study
Official title: 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.
Read more
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.
- Conditions
- Vestibular Schwannoma
- Being tested
- Use of navigation system
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of navigation systemDevice
Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound
| Study group | Role | What they receive |
|---|---|---|
| SBN arm | We will evaluate the feasibility of using an integrated navigation system incorporating pre-operative MRI and intraoperative ultrasound images Receives: Device: Use of navigation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Composite of quantitative and qualitative measurements to assess the system's functionality and technical performance
Measured: 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
Secondary outcomes (4)
Correlation of electromyographic stimulation of facial nerve with preoperatively acquired diffusion imaging
Stimulation response (binary outcome) and amplitude (mA)
Measured: 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
Postoperative tumour volume on contrast-enhanced MRI and its correlation with the final intraoperative ultrasound measurement
Tumour volume (cm3) on MRI and US
Measured: Final intraoperative US volume vs post op MRI volume (within 3 months)
Average duration of surgical procedure using 3D navigation system
Time (hours)
Measured: From start time to end time of each surgical procedure, assessed on 1 day
Documentation of technical system issues and implemented solutions
Documentation of technical system issues and implemented solutions (using qualitative research methods)
Measured: From start time to end time of each surgical procedure, assessed on 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 May 2019
- Primary completionOct 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128345
- Sponsor's protocol ID
- 17/0661
- Acronym
- SBN
- Status last verified
- Oct 2019
- First submitted
- 18 Sep 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Multimodality Imaging Techniques for Neurosurgical Planning and Stereotactic Navigation in Lateral Skull Base Surgery: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04128345
- Acronym / sponsor ID
- SBN / 17/0661
- Conditions
- Vestibular Schwannoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 1 May 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBN arm | – | Device: Use of navigation systemWe will evaluate the feasibility of using an integrated navigation system incorporating pre-operative MRI and intraoperative ultrasound images |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 - 85 years with a vestibular schwannoma who are scheduled for surgery and able to provide written informed consent.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of navigation systemFeasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound | Device | SBN arm |
Primary outcome
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
Composite of quantitative and qualitative measurements to assess the system's functionality and technical performance
4 secondary outcomes
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
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)
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
Documentation of technical system issues and implemented solutions
Time frame: From start time to end time of each surgical procedure, assessed on 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Vestibular Schwannoma
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Mapping of Vestibular Centers Activation Using fMRI in Patients With Vestibular Schwannoma
Vestibular Schwannoma, Unilateral Vestibular Deficit
Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
RecruitingObservational study
3D MRE-Based Evaluation of Vestibular Schwannoma Mechanical Properties and Histological Features
Vestibular Schwannoma
RecruitingObservational study
Natural History Study of Patients With Neurofibromatosis Type 2
Neurofibromatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Schwannoma, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Emerton (00 44 20 3447 7428, semerton@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.