Informations générales (source: ClinicalTrials.gov)

NCT04613349 En recrutement IDF
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors (NEFAPA)
Observational
  • Tumeurs de la parotide
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
janvier 2021
mai 2025
29 juin 2024
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.

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH Stéphane HANS Recrutement non commencé 15/05/2025 05:26:32  Contacter
HOPITAL FONDATION A. DE ROTHSCHILD Luca LITMAN ROVENTA En recrutement IDF 21/06/2024 13:33:27  Contacter

Critères

Tous
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



- 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