Novel Multimodality Imaging for Navigation in Skull Base Surgery

NCT04128345 | Unknown DMC

• 1 other identifier: 17/0661
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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)

• Average duration of surgical procedure using 3D navigation system

  From start time to end time of each surgical procedure, assessed on 1 day

• Documentation of technical system issues and implemented solutions

  From start time to end time of each surgical procedure, assessed on 1 day

Study Arms (1)

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

Interventions

Use of navigation system DEVICE

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

SBN arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College London/University College London Hospitals Joint Research Office

London, WC1E 6BT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Central Study Contacts

Suzanne Emerton

CONTACT

00 44 20 3447 7428; semerton@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 16, 2019
• Study Start: May 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: May 1, 2021
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)