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

Parotid Tumor Clinical Trial

— FACPAR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04104802
• Other study ID #: ACN_2019_12
• Status: Withdrawn
• Start date: October 2019
• Est. completion date: October 2021

Study information

• Verified date: February 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2021
• Est. primary completion date: October 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parotid Neoplasms
• Parotid Tumor

Intervention

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

Locations

Country	Name	City	State
France	Fondation Adolphe De Rothschild	Paris
France	Hôpital Saint Joseph	Paris
France	Institut Arthur Vernes	Paris
France	Hôpital FOCH	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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