Recruiting

NCT Number: NCT04613349

FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

1. 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). 2. nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI. 3. rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.

Recruiting

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Key information

Conditions

Parotid Tumor Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Parotid Diseases Parotid Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation A De Rothschild

Paris, PARIS, 75019, France

Location status: Recruiting

Location contact

Elisabeth SAUVAGET

PRINCIPAL_INVESTIGATOR

Stéphane HANS

PRINCIPAL_INVESTIGATOR

a YAVCHITZ

CONTACT

[email protected]

0148036454

adrien Collin

PRINCIPAL_INVESTIGATOR

jean-Baptiste Lecanu

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

All patients included will benefit from the two methods of evaluating the anatomical relationships between the facial nerve and the parotid tumor:

New medical imaging technique evaluated: high-resolution 3 Tesla parotid MRI with specific sequences and gadolinium injection;
Gold standard: Intraoperative examination.

Primary outcomes

measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.

Time frame: 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

Time frame: day 0

assessment by the surgeon during the excision surgery of the parotid lesion

Study contacts

Contact information is provided by the study sponsor or research team.

Adrien COLLIN

CONTACT

[email protected]

0148036401

Amelie YAVCHITZ

CONTACT

[email protected]

0148036454

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: NEFAPA

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Nov 3, 2020
Registry last updated: Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed