Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

Not Applicable

Recruiting

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

• Registration Number: NCT05296109
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging group	Magnetic Resonance Imaging on 3T scanner (Magnetom Prisma, SIemens) with dedicated neurogram sequences (Constructive interference in steady state - CISS; Dual Echo Steady State - DESS)	patients with parotid tumour being imaged

Primary Outcome Measures

Name	Time	Method
visualization of the major branches of the facial nerve on MRI sequences	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.

Secondary Outcome Measures

Name	Time	Method
Diagnostic value of multi-parametric MRI	At MRI scan before therapeutic intervention (operation or radiofrequency ablation)	The sensitivity, specificity and accuracy of MRI on distinguishing benign and malignant parotid tumours using DWI and DCE-MRI.

Trial Locations

Locations (1)

Gerald Choa MRI Center; 🇭🇰 Hong Kong, Hong Kong