Intra-parotid Facial Nerve Tractography

Parotid Tumor Clinical Trial

— R-PO19053  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950323
• Other study ID #: PO19053
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: June 24, 2021

Study information

• Verified date: April 2020
• Source: CHU de Reims
• Contact: Marc LABROUSSE
• Phone: 03 26 78 37 81
• Email: mlabrousse[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 24, 2021
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parotid Neoplasms
• Parotid Tumor

Intervention

Radiation:
• MRI with Facial nerve tractography
MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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