FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

Parotid Tumor Clinical Trial

— NEFAPA  

Official title:

FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613349
• Other study ID #: 2020-A02019-30
• Status: Recruiting
• Start date: January 13, 2021
• Est. completion date: May 13, 2025

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amelie YAVCHITZ
• Phone: 0148036454
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: May 13, 2025
• Est. primary completion date: January 13, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parotid Neoplasms
• Parotid Tumor

Intervention

Other:
• MRI
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.

Locations

Country	Name	City	State
France	Fondation A De Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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