Novel Multimodality Imaging for Navigation in Skull Base Surgery

• Conditions: Vestibular Schwannoma
• Interventions: Device: Use of navigation system

• Registration Number: NCT04128345
• Lead Sponsor: University College, London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-09-18
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Study First Posted: 2019-10-16
• Last Update Posted: 2019-10-16
• Primary Completion: 2020-10
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SBN arm	Use of navigation system	We will evaluate the feasibility of using an integrated navigation system incorporating pre-operative MRI and intraoperative ultrasound images

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College London/University College London Hospitals Joint Research Office; 🇬🇧 London, United Kingdom