Parotid NeoplasmsNCT05296109
Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation
A study testing Magnetic Resonance Imaging on 3T scanner (Magnetom Prisma, SIemens) with dedicated neurogram sequences (Constructive interference in steady state - CISS; Dual Echo Steady State - DESS) in people with Parotid Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Neoplasms
- What is being tested?
- Magnetic Resonance Imaging on 3T scanner (Magnetom Prisma, SIemens) with dedicated neurogram sequences (Constructive interference in steady state - CISS; Dual Echo Steady State - DESS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Gerald Choa MRI Center
Hong Kong
Gerald Choa MRI Center CUHK, 35051009, cumri@cuhk.edu.hk
About this study
Official title: 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.
- Conditions
- Parotid Neoplasms
- Being tested
- Magnetic Resonance Imaging on 3T scanner (Magnetom Prisma, SIemens) with dedicated neurogram sequences (Constructive interference in steady state - CISS; Dual Echo Steady State - DESS)
- Medical subject headings
- Parotid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Imaging group | Experimental | patients with parotid tumour being imaged Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At MRI scan before therapeutic intervention (operation or radiofrequency ablation)
Secondary outcomes (1)
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.
Measured: At MRI scan before therapeutic intervention (operation or radiofrequency ablation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Feb 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leung Ho Sang, Chinese University of Hong Kong
- Investigators
- Ho Sang Leung, MBBS (HK), Principal investigator, Department of Imaging and Interventional Radiology, Prince of Wales HospitalChiu Wing WInnie Chu, MD, FHKCR, Study director, Department of Imaging and Interventional Radiology, Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296109
- Sponsor's protocol ID
- CREC 2021.639
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared includes individual participant data that underlie the results reported in this article, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Magnetic Resonance Neurogram Sequences for Evaluation of Intraparotid Facial Nerves in Patients With Parotid Neoplasm
- ClinicalTrials.gov ID
- NCT05296109
- Acronym / sponsor ID
- CREC 2021.639
- Conditions
- Parotid Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging group | Experimental | 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)patients with parotid tumour being imaged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Diagnostic test | Imaging group |
Primary outcome
visualization of the major branches of the facial nerve on MRI sequences
Time frame: 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.
1 secondary outcome
Diagnostic value of multi-parametric MRI
Time frame: At MRI scan before therapeutic intervention (operation or radiofrequency ablation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. Data to be shared includes individual participant data that underlie the results reported in this article, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ho Sang Leung, MBBS (HK) principal investigator
Department of Imaging and Interventional Radiology, Prince of Wales Hospital
Chiu Wing WInnie Chu, MD, FHKCR study director
Department of Imaging and Interventional Radiology, Prince of Wales Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging on 3T scanner (Magnetom Prisma, SIemens) with dedicated neurogram sequences (Constructive interference in steady state - CISS; Dual Echo Steady State - DESS) in people with Parotid Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerald Choa MRI Center CUHK (852-35051009, cumri@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visualization of the major branches of the facial nerve on MRI sequences (time frame: At MRI scan before therapeutic intervention (operation or radiofrequency ablation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.