NEFAPA: FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT04613349

Collaborator

(none)

Enrollment

Location

51.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (> 5 mm).
nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI.
rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.

Condition or Disease	Intervention/Treatment	Phase
Parotid Tumor	Other: MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

88 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

Actual Study Start Date :

Jan 13, 2021

Anticipated Primary Completion Date :

Jan 13, 2025

Anticipated Study Completion Date :

May 13, 2025

Outcome Measures

Primary Outcome Measures

measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences. [day 0]
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
assessment by the surgeon during the excision surgery of the parotid lesion [day 0]
assessment by the surgeon during the excision surgery of the parotid lesion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patient over 18 years old
Patient candidate for first line surgery for a parotid tumor
Parotid tumor located near the trunk of the facial nerve and or its first branches of division according to the clinical examination of the ENT surgeon and the imaging data
Affiliate or beneficiary of a social security scheme
Written consent to participate in the study

Exclusion Criteria:

Personal history of parotid homolateral surgery
Absolute or relative contraindication to MRI
Known hypersensitivity to gadolinic contrast media
Pre or post operative period of a liver transplant
Patient benefiting from a legal protection measure
Pregnant or lactating woman
Patient who has already benefited from a preoperative MRI to characterize a complete, well conducted and interpretable parotid lesion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation A De Rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04613349

Other Study ID Numbers:

2020-A02019-30

First Posted:

Nov 3, 2020

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parotid Neoplasms

Study Results

No Results Posted as of Mar 21, 2022