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

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

Study Overview

• Status: Withdrawn
• Conditions: Parotid Tumor
• Intervention / Treatment: Device: MRI

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 Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Fondation Adolphe de Rothschild
  • Paris, France
    • Hôpital Saint Joseph
  • Paris, France
    • Institut Arthur Vernes
  • Suresnes, France
    • Hopital FOCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient candidate for first-line surgery for a parotid tumor

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	1 day

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Mouth Neoplasms; Parotid Diseases; Salivary Gland Neoplasms; Parotid Neoplasms
• Other Study ID Numbers: ACN_2019_12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No