NCT04104802

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Parotid Tumor

Interventions

Type	Name	Description
DEVICE	MRI	All patients included will benefit from both methods of assessing anatomical relationships between the facial nerve and the parotid tumor: 1\) New medical imaging technique evaluated: 3 Tesla Parotidic MRI High Resolution with Specific Sequences and Gadolinium Injection 2) Standard Gold: Intraoperative Exam

Timeline

• Start date: 2019-10-01
• Primary completion: 2019-10-01
• Completion: 2021-10-01
• First posted: 2019-09-26
• Last updated: 2020-02-25

Locations

4 sites across 1 country: France