R-PO19053: Intra-parotid Facial Nerve Tractography

• Sponsor: CHU de Reims (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03950323
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parotid Tumor	Radiation: MRI with Facial nerve tractography	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors
• Actual Study Start Date: Jun 24, 2019
• Anticipated Primary Completion Date: Dec 24, 2020
• Anticipated Study Completion Date: Jun 24, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Facial nerve's path [Day 0]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damien JOLLY	Reims		France

Sponsors and Collaborators

• CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHU de Reims
• ClinicalTrials.gov Identifier: NCT03950323
• Other Study ID Numbers: PO19053
• First Posted: May 15, 2019
• Last Update Posted: Apr 14, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CHU de Reims: Parotidetomy; Tractography; Facial nerve; Facial palsy; Tumor of parotid gland
• Additional relevant MeSH terms: Parotid Neoplasms

Study Results

No Results Posted as of Apr 14, 2020