Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

NCT05296109 | Recruiting

• 1 other identifier: CREC 2021.639
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parotid Neoplasms

Outcome Measures

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.

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

Secondary Outcomes (1)

• Diagnostic value of multi-parametric MRI

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

Study Arms (1)

Imaging group

EXPERIMENTAL

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)

Interventions

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)

Imaging group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Gerald Choa MRI Center

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Study Officials

• Ho Sang Leung, MBBS (HK)

  Department of Imaging and Interventional Radiology, Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

• Chiu Wing WInnie Chu, MD, FHKCR

  Department of Imaging and Interventional Radiology, Prince of Wales Hospital

  STUDY DIRECTOR

Central Study Contacts

Gerald Choa MRI Center CUHK

CONTACT

852-35051009; cumri@cuhk.edu.hk

Ho Sang Leung, MBBS (HK)

CONTACT

852-55699208; lhs655@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident and Honorary Clinical Tutor

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 25, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 3 years after publication of article.
• 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//)

Locations

HK (1)