Parotid TumorR-PO19053NCT03950323
Intra-parotid Facial Nerve Tractography
A study testing MRI with Facial nerve tractography in people with Parotid Tumor, run by CHU de Reims at 1 site in France.
Trial summary
The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Tumor
- What is being tested?
- MRI with Facial nerve tractography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2019to 24 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Major patient
- Patient with initial parotid mass or recurrent
- Parotidian mass with surgical indication
- Benign or malignant
- With or without preoperative facial paralysis
- Patients consenting the protocol
Who cannot join
- Parotidian masses without surgical indication
- Patient with a classic contraindication to MRI
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Marc LABROUSSE, 03 26 78 37 81 ext. 0033, mlabrousse@chu-reims.fr
About this study
Official title: Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors
The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively.
Read the detailed description
Surgery is the main treatment for parotid tumol, benign or malignant pathologies. The procedure requires a trunk search and a facial nerve dissection along its intraparotid length. This intervention entails a risk of facial paralysis.
MRI tractography is a new imaging technique that can characterize nerve fibers and their path.
The interest would be to allow the surgeon to best prepare the parotidectomy by locating the tumor in relation to the trunk and all the branches of the facial nerve.
- Conditions
- Parotid Tumor
- Being tested
- MRI with Facial nerve tractography
- Keywords
- Parotidetomy, Tractography, Facial nerve, Facial palsy, Tumor of parotid gland
- Medical subject headings
- Parotid Neoplasms, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with Facial nerve tractographyRadiation
MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.
| Study group | Role | What they receive |
|---|---|---|
| patients operated on for parotid tumor | Experimental | All consecutive patients operated on for parotid tumor. Receives: Radiation: MRI with Facial nerve tractography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial nerve's path
Relations between the facial nerve's (the facial nerve's trunk s and the facial nerve's dissections) and the parotid gland will be studied. The nerve will be
- in front of the mass or behind the mass
- below the mass or above the mass
- outside the mass or inside the mass
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start24 Jun 2019
- Primary completion24 Dec 2020 (estimated)
- Study completion24 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid TumorStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950323
- Sponsor's protocol ID
- PO19053
- Acronym
- R-PO19053
- Status last verified
- Apr 2020
- First submitted
- 13 May 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors
- ClinicalTrials.gov ID
- NCT03950323
- Acronym / sponsor ID
- R-PO19053 / PO19053
- Conditions
- Parotid Tumor
- Keywords
- Parotidetomy, Tractography, Facial nerve, Facial palsy, Tumor of parotid gland
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 24 Dec 2020 (estimated)
- Study completion
- 24 Jun 2021 (estimated)
- First posted
- 15 May 2019 (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.
The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively.
Detailed description
Surgery is the main treatment for parotid tumol, benign or malignant pathologies. The procedure requires a trunk search and a facial nerve dissection along its intraparotid length. This intervention entails a risk of facial paralysis.
MRI tractography is a new imaging technique that can characterize nerve fibers and their path.
The interest would be to allow the surgeon to best prepare the parotidectomy by locating the tumor in relation to the trunk and all the branches of the facial nerve.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients operated on for parotid tumor | Experimental | Radiation: MRI with Facial nerve tractographyAll consecutive patients operated on for parotid tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major patient
- Patient with initial parotid mass or recurrent
- Parotidian mass with surgical indication
- Benign or malignant
- With or without preoperative facial paralysis
Key exclusion criteria (2 listed)
- Parotidian masses without surgical indication
- Patient with a classic contraindication to MRI
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 |
|---|---|---|
| MRI with Facial nerve tractographyMRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging. | Radiation | patients operated on for parotid tumor |
Primary outcome
Facial nerve's path
Time frame: Day 0
Relations between the facial nerve's (the facial nerve's trunk s and the facial nerve's dissections) and the parotid gland will be studied. The nerve will be * in front of the mass or behind the mass * below the mass or above the mass * outside the mass or inside the mass
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI with Facial nerve tractography in people with Parotid Tumor, run by CHU de Reims at 1 site in France.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Apr 2020. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc LABROUSSE (03 26 78 37 81 ext. 0033, mlabrousse@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial nerve's path (time frame: Day 0). 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 14 Apr 2020.