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

NCT04104802 | Withdrawn

• 1 other identifier: ACN_2019_12
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

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

Conditions

Parotid Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

MRI DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient candidate for first-line surgery for a parotid tumor

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (4)

Fondation Adolphe De Rothschild

Paris, France

Location

Hôpital Saint Joseph

Paris, France

Location

Institut Arthur Vernes

Paris, France

Location

Hôpital FOCH

Suresnes, France

Location

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: September 26, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2021
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

FR (4)