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临床试验/NCT04057976
NCT04057976已完成不适用

The Accuracy of Advanced Probabilistic Diffusion Tensor Tractography (DTT) for the Pre-operative Identification of Facial Nerve Position in Patients With Extrameatal Vestibular Schwannomas.

King's College Hospital NHS Trust2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Accuracy of probabilistic diffusion tensor tractography (DTT)

研究概览

简要总结

Vestibular schwannomas (VS) arise from the vestibulocochlear (hearing and balance) nerve, located at the base of the brain. Although benign, VS can enlarge over time, resulting in debilitating symptoms; therefore, surgical removal is frequently offered. One significant risk of surgery is inadvertent injury to the facial nerve, which lies adjacent to the vestibulocochlear nerve. Currently, the nerve's course is only revealed during surgical dissection and injury can cause permanent facial weakness. It would therefore be useful for the surgeon to know the course of the nerve before operating. To this end, a new MRI technique known as probabilistic diffusion tensor tractography (DTT) has shown potential in revealing the course of the facial nerve pre-operatively. However, its clinical reliability remains uncertain.

This study aims to investigate the reliability of DTT in identifying the course of the facial nerve preoperatively in patients undergoing surgery for VS.

The future benefit would be to enable surgeons to operate with more confidence and potentially reduce the chance of nerve injury.

The study will recruit adult patients due to have surgery for VS. The only change to the participants' clinical pathways will be the addition of a DTT sequence to their pre-operative MRI scans (increasing scanning time by approximately 10 minutes).

详细描述

BACKGROUND AND RATIONALE Vestibular schwannomas (VS) are peripheral nerve sheath tumours arising from the vestibulocochlear nerve, which emerges from the brainstem at the base of the brain and enters the structures of the inner ear via a small bony canal within the skull (internal auditory meatus). VS account for 8% (Johnson J et al.) of intracranial tumours and, although benign, these tumours can grow resulting in several potentially debilitating symptoms, including hearing loss, vertigo, tinnitus, facial paralysis and meningitis. Furthermore, large tumours may cause compression on the brainstem, which can, in some cases, have life-threatening consequences (Johnson J et al.). Therefore, patients diagnosed with larger tumours (>1.5cm extrameatal component) are frequently offered surgical resection (as opposed to conservative management or stereotactic radiosurgery). As surgical techniques have improved, the goal of surgery has broadened to include not only tumour removal, but also preservation of the function of the nerves involved by VS. In particular, surgical resection aims to preserve the function of the facial nerve, responsible for innervating the muscles of facial expression, and which runs alongside the vestibulocochlear nerve and is frequently displaced and flattened by VS. Given its juxtaposition, the facial nerve is at high risk of injury during surgery. Injury to the facial nerve (and consequent debilitating facial weakness or paralysis) is a serious potential risk of vestibular schwannoma (VS) surgery. However, at present, the only means of avoiding nerve injury involves a combination of meticulous surgical technique and the use of a facial nerve monitor (a device that can detect activity within the facial muscles when stimulated by a surgeon-held probe); however, despite this, facial nerve injury may still occur. Indeed, until the surgeon begins operating, the course of the facial nerve is unknown. In a large series (>1000 surgical cases) by Sampath et al., the position of the facial nerve position was found most commonly on the anterior middle portion of the tumour; however, in a smaller proportion of cases, the nerve lay in 1 of 7 additional locations (Sampath et al.). Therefore, it follows that preoperative detection and identification of the course of the facial nerve would be extremely useful to guide surgery and reduce the potential risk of neuronal injury.

There now exists a potential means of non-invasively identifying the course of the facial nerve using advanced applications of magnetic resonance imaging (MRI). This involves utilising a technique known as diffusion tensor tractography (DTT), which has the capacity to detect the direction (vector) of diffusivity in a particular volume of tissue (voxel) (Mukherjee et al.). This data can be subsequently used to reveal structures, such as nerve fibre tracts, that are arranged along particular vectors, enabling them to be differentiated from surrounding tissue (Cauley et al.). This cannot be achieved using standard MRI sequences, in which the flattened nerve often becomes indistinguishable from the adjacent VS. Fortunately, as MRI represents the current means of diagnosing and characterising VS, adding an additional DTT sequence to a patient's scan does not represent a significant burden (only approximately 10 additional minutes of scanning time to acquire the DTT data).

Several groups (Choi et al., Taoka et al., Gerganov et al., Zhang et al. and Song et al.) have used DTT to delineate the course of the facial nerve in patients with VS and the majority have reported high success rates (>90% agreement with operative findings). However, many of these studies employed 'deterministic' DTT, which has drawbacks that limit its reliability in the setting of small fibre tracts with complex geometry. In particular, it is unable to accurately track fibres that cross, split or merge because the technique assumes that adjacent voxels have similar vectors. In order to overcome these limitations, we propose using the newer 'probabilistic' DTT technique that calculates a vector for each voxel analysed. It therefore has the capacity to account for complex geometries, such as those encountered in the facial nerve, particularly where its course is heavily distorted by tumour tissue. Zolal et al. used this technique in 21 patients with VS, resulting in an agreement rate of 81% for the position of the facial nerve and 33% for the cochlear nerve (Zolal et al.). However, there is an ongoing need for further studies in this area.

This project seeks to clarify the accuracy, reproducibility and practicality of probabilistic DTT in locating the facial nerve pre-operatively. If the technique proves accurate, it will potentially help with pre-operative planning and avoidance of facial nerve injury during VS surgery. Additionally the project seeks to clarify associated practical issues; in particular, the inter-observer/intra-observer variability (i.e. whether the reading radiologists agree with each other and themselves when analysing DTT images), whether the facial nerve position can be partially inferred on conventional sequences (comparing this with DTT) and whether adjacent nerves (such as the vestibulocochlear nerve) can be identified, which may further help with surgical preoperative planning.

HYPOTHESIS:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The capacity to understand the patient information sheet and the ability to provide written informed consent
  • >1.5cm extrameatal tumor determined to represent a vestibular schwannoma by preoperative imaging
  • HB grade I or II preoperatively

排除标准

  • Patients not meeting the above inclusion criteria
  • Standard contraindications to MRI
  • Previous cranial radiotherapy or previous surgery to the cerebellopontine angle cistern or IAM

结局指标

主要结局

Accuracy of probabilistic diffusion tensor tractography (DTT)

时间窗: 4 years

To assess the accuracy of pre-operative probabilistic DTT in determining the position of the facial nerve (relative to extrameatal portion of a vestibular schwannoma) by using the facial nerve position at surgery as a reference standard.

次要结局

  • Reproducibility(4 years)
  • Relationship of tumour size with accuracy(4 years)
  • Facial nerve shape(4 years)
  • Relationship of tumour size with confidence(4 years)
  • Comparison of DTT with conventional anatomical sequence(4 years)
  • Assessment of adjacent CPA nerves.(4 years)

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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