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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-31

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

NCT04613349

Parotid Tumor

RECRUITING

Intra-parotid Facial Nerve Tractography

NCT03950323

Parotid Tumor

UNKNOWN NA

Intra-parotid Facial Nerve Imaging in Parotidectomy

NCT03822728

Parotid Tumors Facial Nerve Paresis

COMPLETED NA

MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors

NCT05152056

Parotid Tumor

COMPLETED

Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

NCT05296109

Parotid Neoplasms

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Parotid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No