FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

NCT04613349 | Recruiting

• 1 other identifier: 2020-A02019-30
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.

Conditions

Parotid Tumor

Outcome Measures

Primary Outcomes (2)

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

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

  day 0

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

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

  day 0

Interventions

MRI OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient candidate for first line surgery for a parotid tumor

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation A De Rothschild

Paris, PARIS, 75019, France

RECRUITING

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Amelie YAVCHITZ

CONTACT

0148036454; ayavchitz@for.paris

Adrien COLLIN

CONTACT

0148036401; acollin@for.paris

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: November 3, 2020
• Study Start: January 13, 2021
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): May 13, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)