Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parotid Neoplasms
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerald Choa MRI Center CUHK; Phone Number: 852-35051009; Email: cumri@cuhk.edu.hk
• Study Contact Backup: Name: Ho Sang Leung, MBBS (HK); Phone Number: 852-55699208; Email: lhs655@ha.org.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Gerald Choa MRI Center
    • Contact: Gerald Choa MRI Center CUHK; Phone Number: 35051009; Email: cumri@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Imaging group; patients with parotid tumour being imaged

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); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At MRI scan before therapeutic intervention (operation or radiofrequency ablation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At MRI scan before therapeutic intervention (operation or radiofrequency ablation)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Ho Sang Leung, MBBS (HK), Department of Imaging and Interventional Radiology, Prince of Wales Hospital; Study Director: Chiu Wing WInnie Chu, MD, FHKCR, Department of Imaging and Interventional Radiology, Prince of Wales Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Salivary Gland Diseases; Mouth Neoplasms; Parotid Diseases; Salivary Gland Neoplasms; Parotid Neoplasms
• Other Study ID Numbers: CREC 2021.639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data to be shared includes individual participant data that underlie the results reported in this article, after deidentification.
• IPD Sharing Time Frame: Within 3 years after publication of article.
• IPD Sharing Access Criteria: Proposals should be directed to lhs655@ha.org.hk. To gain access, data requestors will need to sign a data access agreement. Data are available for 3 years at CUHK research data repository. (https://researchdata.cuhk.edu.hk//)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No