Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

    The MRI examination will consist of both conventional sequences for diagnosis of salivary gland neoplasms (including DWI and DCE-MRI), together with additional neurogram sequences. (please refer to attached protocol for list of sequences)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Imaging groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
At MRI scan before therapeutic intervention (operation or radiofrequency ablation)

Secondary outcomes

1

Diagnostic value of multi-parametric MRI

The sensitivity, specificity and accuracy of MRI on distinguishing benign and malignant parotid tumours using DWI and DCE-MRI.

Time frame
At MRI scan before therapeutic intervention (operation or radiofrequency ablation)

Other outcomes

Sponsors and contacts

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