Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05296109
Collaborator
(none)
50
1
1
16.9
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Application of 3D Magnetic Resonance Neurogram Sequences for Evaluation of Intraparotid Facial Nerves in Patients With Parotid Neoplasm
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gerald Choa MRI Center Hong Kong Hong Kong

Sponsors and Collaborators

  • 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 Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Leung Ho Sang, Resident and Honorary Clinical Tutor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05296109
Other Study ID Numbers:
  • CREC 2021.639
First Posted:
Mar 25, 2022
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022