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Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

Primary Purpose

Parotid Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Magnetic Resonance Imaging on 3T scanner (Magnetom Prisma, SIemens) with dedicated neurogram sequences (Constructive interference in steady state - CISS; Dual Echo Steady State - DESS)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parotid Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gerald Choa MRI CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging group

Arm Description

patients with parotid tumour being imaged

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 25, 2022
Last Updated
September 7, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05296109
Brief Title
Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation
Official Title
Application of 3D Magnetic Resonance Neurogram Sequences for Evaluation of Intraparotid Facial Nerves in Patients With Parotid Neoplasm
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parotid Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging group
Arm Type
Experimental
Arm Description
patients with parotid tumour being imaged
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Imaging on 3T scanner (Magnetom Prisma, SIemens) with dedicated neurogram sequences (Constructive interference in steady state - CISS; Dual Echo Steady State - DESS)
Intervention Description
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 Outcome Measure Information:
Title
visualization of the major branches of the facial nerve on MRI sequences
Description
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.
Time Frame
At MRI scan before therapeutic intervention (operation or radiofrequency ablation)
Secondary Outcome Measure Information:
Title
Diagnostic value of multi-parametric MRI
Description
The sensitivity, specificity and accuracy of MRI on distinguishing benign and malignant parotid tumours using DWI and DCE-MRI.
Time Frame
At MRI scan before therapeutic intervention (operation or radiofrequency ablation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Choa MRI Center CUHK
Phone
852-35051009
Email
cumri@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Sang Leung, MBBS (HK)
Phone
852-55699208
Email
lhs655@ha.org.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Sang Leung, MBBS (HK)
Organizational Affiliation
Department of Imaging and Interventional Radiology, Prince of Wales Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chiu Wing WInnie Chu, MD, FHKCR
Organizational Affiliation
Department of Imaging and Interventional Radiology, Prince of Wales Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gerald Choa MRI Center
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Choa MRI Center CUHK
Phone
35051009
Email
cumri@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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//)

Learn more about this trial

Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

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