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: Unknown
• Conditions: Vestibular Schwannoma
• Intervention / Treatment: Device: Use of navigation system

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Suzanne Emerton; Phone Number: 00 44 20 3447 7428; Email: semerton@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, WC1E 6BT
    • Recruiting
    • University College London/University College London Hospitals Joint Research Office
    • Contact: Misha Ladva; Phone Number: 02034475199; Email: randd@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 - 85 years with a vestibular schwannoma who are scheduled for surgery and able to provide written informed consent.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SBN arm; We will evaluate the feasibility of using an integrated navigation system incorporating pre-operative MRI and intraoperative ultrasound images	Device: Use of navigation system; Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University College London Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No