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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03950323
Other study ID # PO19053
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Not yet recruiting NCT05401370 - Role of Methylene Blue in Parotid Surgery N/A
Completed NCT01414790 - The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome Phase 3
Recruiting NCT04613349 - FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
Completed NCT04803032 - Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy N/A