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FArial NErf MRI in the Preoperative Assessment of PArotide Tumors (NEFAPA)

F

Fondation Ophtalmologique Adolphe de Rothschild

Status

Enrolling

Conditions

Parotid Tumor

Treatments

Other: MRI

Study type

Observational

Funder types

NETWORK

Identifiers

NCT04613349
2020-A02019-30

Details and patient eligibility

About

  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.

Enrollment

88 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Amelie YAVCHITZ; Adrien COLLIN

Data sourced from clinicaltrials.gov

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