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NCT Number: NCT05296109

Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerald Choa MRI Center

Hong Kong

Location status: Recruiting

Location contact

Gerald Choa MRI Center CUHK

CONTACT

[email protected]

35051009

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

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)

Primary outcomes

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

    Time frame: 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 outcomes

  1. Diagnostic value of multi-parametric MRI

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gerald Choa MRI Center CUHK

CONTACT

[email protected]

852-35051009

Ho Sang Leung, MBBS (HK)

CONTACT

[email protected]

852-55699208

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2022
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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