Novel Multimodality Imaging for Navigation in Skull Base Surgery

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04128345
Study type	Observational
Source	University College, London
Contact	Suzanne Emerton
Phone	00 44 20 3447 7428
Email	semerton@nhs.net
Status	Recruiting
Phase
Start date	May 1, 2019
Completion date	May 2021

View Details

See also
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Completed	`NCT04351373` - Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560	Phase 2
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Completed	`NCT01207687` - Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)	Phase 2
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Completed	`NCT02249572` - Vestibular Schwannoma - Radiosurgery or Expectation: V-REX.	N/A
Terminated	`NCT05116878` - Enhancing Facial Nerve Function With Omega-3 After Resection of Vestibular Schwannoma	N/A
Suspended	`NCT03095248` - Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors	Phase 2
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Recruiting	`NCT04057976` - Use of DTT to Define Facial Nerve Position in Vestibular Schwannomas	N/A
Completed	`NCT00863122` - Concentration and Activity of Lapatinib in Vestibular Schwannomas	Early Phase 1
Recruiting	`NCT04374305` - Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)	Phase 2
Recruiting	`NCT03079999` - Study of Aspirin in Patients With Vestibular Schwannoma	Phase 2
Recruiting	`NCT05786144` - Vestibular Schwannoma Organoids
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Completed	`NCT03210285` - WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Novel Multimodality Imaging for Navigation in Skull Base Surgery — SBN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms