Intra-parotid Facial Nerve Tractography

NCT ID: NCT03950323

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2021-06-24

Brief Summary

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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

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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.

Conditions

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Parotid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients operated on for parotid tumor

All consecutive patients operated on for parotid tumor.

Group Type EXPERIMENTAL

MRI with Facial nerve tractography

Intervention Type RADIATION

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

Interventions

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MRI with Facial nerve tractography

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marc LABROUSSE

Role: CONTACT

03 26 78 37 81 ext. 0033

Facility Contacts

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Marc LABROUSSE

Role: primary

03 26 78 37 81 ext. 0033

Other Identifiers

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PO19053

Identifier Type: -

Identifier Source: org_study_id

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