FArial NErf MRI in the Preoperative Assessment of PArotide Tumors (NEFAPA)

December 30, 2025 updated by: Fondation Ophtalmologique Adolphe de Rothschild
  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • PARIS
      • Paris, PARIS, France, 75019
        • Recruiting
        • Fondation A de Rothschild
        • Contact:
        • Principal Investigator:
          • adrien Collin
        • Principal Investigator:
          • jean-Baptiste Lecanu
        • Principal Investigator:
          • Elisabeth SAUVAGET
        • Principal Investigator:
          • Stéphane HANS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patient candidate for first line surgery for a parotid tumor

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 0
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
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2021

Primary Completion (Estimated)

January 13, 2027

Study Completion (Estimated)

May 13, 2027

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02019-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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