FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Parotid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other MRI
All patients included will benefit from the two methods of evaluating the anatomical relationships between the facial nerve and the parotid tumor: 1. New medical imaging technique evaluated: high-resolution 3 Tesla parotid MRI with specific sequences and gadolinium injection; 2. Gold standard: Intraoperative examination.
Primary outcome measures
- measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences. [Time frame: day 0]
- assessment by the surgeon during the excision surgery of the parotid lesion [Time frame: day 0]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Fondation A De Rothschild — Paris
Identifiers
NCT: NCT04613349 · 2020-A02019-30