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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05296109
Other study ID # CREC 2021.639
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date June 30, 2024

Study information

Verified date September 2023
Source Chinese University of Hong Kong
Contact Gerald Choa MRI Center CUHK
Phone 852-35051009
Email cumri@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Hong Kong Gerald Choa MRI Center Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
See also
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Completed NCT04803032 - Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy N/A
Active, not recruiting NCT02294838 - Feasibility Study of MRI Imaging on Parotid Gland Stimulation N/A
Completed NCT02527226 - Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors N/A