Intra-parotid Facial Nerve Tractography (R-PO19053)

Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors

The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively.

Study Overview

• Status: Unknown
• Conditions: Parotid Tumor
• Intervention / Treatment: Radiation: MRI with Facial nerve tractography

Detailed Description

Surgery is the main treatment for parotid tumol, benign or malignant pathologies. The procedure requires a trunk search and a facial nerve dissection along its intraparotid length. This intervention entails a risk of facial paralysis.

MRI tractography is a new imaging technique that can characterize nerve fibers and their path.

The interest would be to allow the surgeon to best prepare the parotidectomy by locating the tumor in relation to the trunk and all the branches of the facial nerve.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc LABROUSSE; Phone Number: 0033 03 26 78 37 81; Email: mlabrousse@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Marc LABROUSSE; Phone Number: 0033 03 26 78 37 81; Email: mlabrousse@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

inclusion criteria :

• Major patient
• Patient with initial parotid mass or recurrent
• Parotidian mass with surgical indication
• Benign or malignant
• With or without preoperative facial paralysis
• Patients consenting the protocol

exclusion criteria :

• Parotidian masses without surgical indication
• Patient with a classic contraindication to MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients operated on for parotid tumor; All consecutive patients operated on for parotid tumor.	Radiation: MRI with Facial nerve tractography; MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial nerve's path	Relations between the facial nerve's (the facial nerve's trunk s and the facial nerve's dissections) and the parotid gland will be studied. The nerve will be; in front of the mass or behind the mass; below the mass or above the mass; outside the mass or inside the mass	Day 0

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Anticipated): December 24, 2020
• Study Completion (Anticipated): June 24, 2021

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Parotidetomy; Tractography; Facial nerve; Facial palsy; Tumor of parotid gland
• 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: PO19053

Drug and device information, study documents

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