Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors

Withdrawn

• Conditions: Parotid Tumor

• Registration Number: NCT04104802
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure

Detailed Description

1. st visit: Inclusion, parotid MRI 3Tesla high resolution with specific sequences and gadolinium injection performed at the A. de Rothschild Foundation. Evaluation by two radiologists of the exact position of the parotid tumor with respect to the trunk of the facial nerve and its first branches, classified into two categories: contact (≤ 5 mm) or distance (\> 5 mm).

2. nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as those collected by the radiologists after the MRI. The surgeon will not be aware of the data concerning the ratios of parotid tumor to facial nerve collected on MRI sequences for research purposes.

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Start: 2019-10
• Primary Completion: 2019-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient over 18 years old
• Patient seeking first-line surgery for a parotid tumor (single or multiple, benign or malignant)
• Parotidian tumor located near the trunk of the facial nerve and / or its first division branches (temporofacial and cervicofacial), during a clinical evaluation performed by the surgeon in preoperative consultation
• Patient affiliated or beneficiary of a social security scheme
• Written consent to participate in the study

Exclusion Criteria

• Personal history of ipsilateral parotid surgery
• Contraindication to MRI (electronic device, metallic foreign body, claustrophobia)
• Known hypersensitivity to gadolinium contrast agents
• Renal impairment known: glomerular filtration rate <30 mL / min
• Pre or post-operative period of liver transplantation
• Patient benefiting from a legal protection measure
• Pregnant or lactating woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the sensitivity of a high-resolution 3 Tesla MRI with gadolinium injection with specific sequences versus intraoperative findings of the surgeon (gold standard), to evaluate the anatomic relationships between parotid tumor and facial nerve.	1 day	Sensitivity of new MRI sequences to determine whether the parotid tumor is in contact or at a distance from the facial nerve (common core and first division branches) in comparison with the intra-operative examination (gold standard).; The contact between the parotid tumor and the trunk of the facial nerve or its first branches of division is a binary qualitative variable with modalities defined as: * "Yes": tumor on contact (distance between the tumor and the trunk of the facial nerve or its first branches between 0 and 5 mm); * "No": trunk of the facial nerve or its first divisional branches located at a distance (ie more than 5mm from the parotid tumor).

Trial Locations

Locations (4)

Institut Arthur Vernes; 🇫🇷 Paris, France

Fondation Adolphe De Rothschild; 🇫🇷 Paris, France

Hôpital Saint Joseph; 🇫🇷 Paris, France

Hôpital FOCH; 🇫🇷 Suresnes, France