跳至主要内容
临床试验/NCT05296109
NCT05296109招募中不适用

Application of 3D Magnetic Resonance Neurogram Sequences for Evaluation of Intraparotid Facial Nerves in Patients With Parotid Neoplasm

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
visualization of the major branches of the facial nerve on MRI sequences

研究概览

简要总结

Parotid neoplasm consists of a wide range of benign and malignant lesions, and parotidectomy has been the mainstay for management of these neoplasms. Within the parotid gland there are branches of the intra-parotid facial nerves, which are tiny in calibre and are prone to injury to injury during operation. It has been reported in recent retrospective view that the incidence of temporary and permanent facial nerve injury were 9.2% and 5.2% respectively, the risk of which increased with old age, malignant tumour and revision surgery. Traditional the incidental of facial nerve injury is reduced by intra-operative facial nerve monitoring and surgical magnification, while imaging has limited role in aiding this purpose. However with advancement in MRI technique high resolution three-dimensional sequences (i.e. neurogram sequences) are available for better visualization of branches of facial nerves. The investigators would therefore aim to demonstrate additional efficacy of these techniques and also to compare with conventional 3D post-contrast anatomical imaging studies in the localization and visualization of the facial nerve branches in patients with tumour. With better pre-operative imaging, the investigators hope to reduce the chance of facial nerve injury in these patients.

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

  • Consecutive patients with parotid tumour diagnosed on other imaging modalities (such as ultrasonography or computed tomography), with or without cytological diagnosis from fine needle aspiration, will be recruited from the ear, nose and throat specialty clinic.

排除标准

  • Patients who are contraindicated to magnetic resonance imaging (such as due to underlying MRI incompatible metallic implants)
  • Patient who are contraindicated to MRI contrast agents (such as advanced renal failure or previous severe allergic reaction)
  • Patients who cannot cooperate for MRI scanning.
  • Patients show are unable to provide informed consent.

研究组 & 干预措施

Imaging group

Experimental

patients with parotid tumour being imaged

干预措施: Magnetic Resonance Imaging on 3T scanner (Magnetom Prisma, SIemens) with dedicated neurogram sequences (Constructive interference in steady state - CISS; Dual Echo Steady State - DESS) (Diagnostic Test)

结局指标

主要结局

visualization of the major branches of the facial nerve on MRI sequences

时间窗: At MRI scan before therapeutic intervention (operation or radiofrequency ablation)

The degree which facial nerve and branches will be visualized, by a three-point scale to each facial nerve branch, after review by radiologist. Total score of facial nerve visualization will be calculated, per MRI sequence per patient.

次要结局

  • Diagnostic value of multi-parametric MRI(At MRI scan before therapeutic intervention (operation or radiofrequency ablation))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leung Ho Sang

Resident and Honorary Clinical Tutor

Chinese University of Hong Kong

研究点 (1)

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