Novel Multimodality Imaging for Navigation in Skull Base Surgery

Vestibular Schwannoma Clinical Trial

— SBN  

Official title:

Novel Multimodality Imaging Techniques for Neurosurgical Planning and Stereotactic Navigation in Lateral Skull Base Surgery: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128345
• Other study ID #: 17/0661
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: May 2021

Study information

• Verified date: October 2019
• Source: University College, London
• Contact: Suzanne Emerton
• Phone: 00 44 20 3447 7428
• Email: semerton[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Device:
• Use of navigation system
Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound

Locations

Country	Name	City	State
United Kingdom	University College London/University College London Hospitals Joint Research Office	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	University College London Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Correlation of electromyographic stimulation of facial nerve with preoperatively acquired diffusion imaging	Stimulation response (binary outcome) and amplitude (mA)	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
Secondary	Postoperative tumour volume on contrast-enhanced MRI and its correlation with the final intraoperative ultrasound measurement	Tumour volume (cm3) on MRI and US	Final intraoperative US volume vs post op MRI volume (within 3 months)
Secondary	Average duration of surgical procedure using 3D navigation system	Time (hours)	From start time to end time of each surgical procedure, assessed on 1 day
Secondary	Documentation of technical system issues and implemented solutions	Documentation of technical system issues and implemented solutions (using qualitative research methods)	From start time to end time of each surgical procedure, assessed on 1 day