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Status unknownNCT03950323R-PO19053Updated Apr 14, 2020

Intra-parotid Facial Nerve Tractography

An interventional study of MRI with Facial nerve tractography in Parotid Tumor, sponsored by CHU de Reims. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-14.

Sponsored by CHU de Reims · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parotid Tumor

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Keywords

  • Parotidetomy
  • Tractography
  • Facial nerve
  • Facial palsy
  • Tumor of parotid gland
03

In context

Parotid Neoplasms

27 studies on the registry are indexed under Parotid Neoplasms; 7 are open to participants now.

This study's planned enrollment of 40 is below the median of 55 across 20 interventional studies indexed under Parotid Neoplasms.

Browse Parotid Neoplasms studies →

Lead sponsor

CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

exclusion criteria :

  • Parotidian masses without surgical indication
  • Patient with a classic contraindication to MRI
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    patients operated on for parotid tumor

    All consecutive patients operated on for parotid tumor.

    Radiation: MRI with Facial nerve tractography

Interventions

  • RadiationMRI with Facial nerve tractography

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03950323
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
May 15, 2019
Start date
Jun 24, 2019
Primary completion
Dec 24, 2020 (estimated)
Completion
Jun 24, 2021 (estimated)
Last update
Apr 14, 2020

Study contacts

Marc LABROUSSE
Contact
mlabrousse@chu-reims.fr
03 26 78 37 81 ext. 0033

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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