Intra-parotid Facial Nerve Tractography | NCT03950323

Studies
Intra-parotid Facial Nerve Tractography

NCT03950323

Sponsor

CHU de Reims

Status

Unknown status

Last Update Posted

Apr 14, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Parotid Tumor

Interventions

MRI with Facial nerve tractography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2019Actual

Primary Completion Date

Dec 24, 2020Estimated

Completion Date

Jun 24, 2021Estimated

First Submitted Date

May 13, 2019

First Submission Date that Met QC Criteria

May 14, 2019

First Posted Date

May 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2020

Last Update Posted Date

Apr 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients operated on for parotid tumor	Experimental	All consecutive patients operated on for parotid tumor.	Radiation: MRI with Facial nerve tractography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI with Facial nerve tractography	Radiation	MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.	patients operated on for parotid tumor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc LABROUSSE	Contact	03 26 78 37 81	0033	mlabrousse@chu-reims.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Damien JOLLY	Recruiting	Reims			France

Condition Browse Module

MeSH Terms

ID	Term
D010307	Parotid Neoplasms
D005158	Facial Paralysis

Ancestor Terms

ID	Term
D012468	Salivary Gland Neoplasms
D009062	Mouth Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided