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Recruiting Observational

FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

NCT04613349 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2021-01-13
Last updated
2026-01-05

Condition(s) studied

Parotid Tumor

Investigational drug(s) / intervention(s)

MRI

MRI: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Fondation A De Rothschild Paris PARIS Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04613349 on ClinicalTrials.gov ↗ ← All trials in France