FArial NErf MRI in the Preoperative Assessment of PArotide Tumors (NCT04613349) | Clinical Trial Compass
RecruitingNot Applicable
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
France88 participantsStarted 2021-01-13
Plain-language summary
1. st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (\> 5 mm).
2. nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI.
3. rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient over 18 years old
* Patient candidate for first line surgery for a parotid tumor
* Parotid tumor located near the trunk of the facial nerve and or its first branches of division according to the clinical examination of the ENT surgeon and the imaging data
* Affiliate or beneficiary of a social security scheme
* Written consent to participate in the study
Exclusion Criteria:
* Personal history of parotid homolateral surgery
* Absolute or relative contraindication to MRI
* Known hypersensitivity to gadolinic contrast media
* Pre or post operative period of a liver transplant
* Patient benefiting from a legal protection measure
* Pregnant or lactating woman
* Patient who has already benefited from a preoperative MRI to characterize a complete, well conducted and interpretable parotid lesion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
Timeframe: day 0
2
assessment by the surgeon during the excision surgery of the parotid lesion
Timeframe: day 0
Trial details
NCT IDNCT04613349
SponsorFondation Ophtalmologique Adolphe de Rothschild