NCT03950323

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2021

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

May 13, 2019

Last Update Submit

April 10, 2020

Conditions

Parotid Tumor

Keywords

ParotidetomyTractographyFacial nerveFacial palsyTumor of parotid gland

Outcome Measures

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

    Day 0

Study Arms (1)

patients operated on for parotid tumor

EXPERIMENTAL

All consecutive patients operated on for parotid tumor.

Radiation: MRI with Facial nerve tractography

Interventions

MRI with Facial nerve tractographyRADIATION

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

patients operated on for parotid tumor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Parotid NeoplasmsFacial Paralysis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Salivary Gland NeoplasmsMouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesParotid DiseasesSalivary Gland DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Marc LABROUSSE

CONTACT

03 26 78 37 81mlabrousse@chu-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

June 24, 2019

Primary Completion

December 24, 2020

Study Completion

June 24, 2021

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

FR(1)