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.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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London, 영국, WC1E 6BT
- 모병
- University College London/University College London Hospitals Joint Research Office
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연락하다:
- Misha Ladva
- 전화번호: 02034475199
- 이메일: randd@ucl.ac.uk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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SBN arm
We will evaluate the feasibility of using an integrated navigation system incorporating pre-operative MRI and intraoperative ultrasound images
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Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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
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Composite of quantitative and qualitative measurements to assess the system's functionality and technical performance
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation of electromyographic stimulation of facial nerve with preoperatively acquired diffusion imaging
기간: 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
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Stimulation response (binary outcome) and amplitude (mA)
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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
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Postoperative tumour volume on contrast-enhanced MRI and its correlation with the final intraoperative ultrasound measurement
기간: Final intraoperative US volume vs post op MRI volume (within 3 months)
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Tumour volume (cm3) on MRI and US
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Final intraoperative US volume vs post op MRI volume (within 3 months)
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Average duration of surgical procedure using 3D navigation system
기간: From start time to end time of each surgical procedure, assessed on 1 day
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Time (hours)
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From start time to end time of each surgical procedure, assessed on 1 day
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Documentation of technical system issues and implemented solutions
기간: From start time to end time of each surgical procedure, assessed on 1 day
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Documentation of technical system issues and implemented solutions (using qualitative research methods)
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From start time to end time of each surgical procedure, assessed on 1 day
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 17/0661
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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