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FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04613349
Acronym
NEFAPA
Enrollment
88
Registered
2020-11-03
Start date
2021-01-13
Completion date
2027-05-13
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parotid Tumor

Brief summary

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.

Interventions

OTHERMRI

All patients included will benefit from the two methods of evaluating the anatomical relationships between the facial nerve and the parotid tumor: 1. New medical imaging technique evaluated: high-resolution 3 Tesla parotid MRI with specific sequences and gadolinium injection; 2. Gold standard: Intraoperative examination.

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactAmelie YAVCHITZ
ayavchitz@for.paris0148036454
Backup ContactAdrien COLLIN
acollin@for.paris0148036401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026