FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

Recruiting

• Conditions: Parotid Tumor

• Registration Number: NCT04613349
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2021-01-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2025-01-13
• Study Completion: 2025-05-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.	day 0	measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
assessment by the surgeon during the excision surgery of the parotid lesion	day 0	assessment by the surgeon during the excision surgery of the parotid lesion

Trial Locations

Locations (1)

Fondation A De Rothschild; 🇫🇷 Paris, France