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Intra-parotid Facial Nerve Tractography (R-PO19053)

Primary Purpose

Parotid Tumor

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI with Facial nerve tractography
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parotid Tumor focused on measuring Parotidetomy, Tractography, Facial nerve, Facial palsy, Tumor of parotid gland

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Damien JOLLYRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients operated on for parotid tumor

Arm Description

All consecutive patients operated on for parotid tumor.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 13, 2019
Last Updated
April 10, 2020
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT03950323
Brief Title
Intra-parotid Facial Nerve Tractography
Acronym
R-PO19053
Official Title
Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
December 24, 2020 (Anticipated)
Study Completion Date
June 24, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parotid Tumor
Keywords
Parotidetomy, Tractography, Facial nerve, Facial palsy, Tumor of parotid gland

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients operated on for parotid tumor
Arm Type
Experimental
Arm Description
All consecutive patients operated on for parotid tumor.
Intervention Type
Radiation
Intervention Name(s)
MRI with Facial nerve tractography
Intervention Description
MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.
Primary Outcome Measure Information:
Title
Facial nerve's path
Description
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
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc LABROUSSE
Phone
03 26 78 37 81
Ext
0033
Email
mlabrousse@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc LABROUSSE
Phone
03 26 78 37 81
Ext
0033
Email
mlabrousse@chu-reims.fr

12. IPD Sharing Statement

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Intra-parotid Facial Nerve Tractography

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