Using MRI to assess parotid tumors before surgery
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
This study is testing if a special type of MRI can help doctors see how close parotid tumors are to the facial nerve before surgery to improve patient outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris, PARIS) |
| Trial ID | NCT04613349 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the use of high-resolution MRI to assess the position of parotid tumors in relation to the facial nerve before surgical intervention. Patients will undergo a 3Tesla MRI as part of routine care, with additional sequences to better characterize the tumor's proximity to the facial nerve. Following the MRI, patients will have surgery to remove the tumor, and post-operative consultations will assess any occurrence of facial paralysis. The study aims to improve surgical outcomes by providing detailed imaging information.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for first-line surgery for a parotid tumor located near the facial nerve.
Not a fit: Patients with a history of parotid surgery, contraindications to MRI, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical planning and reduced risk of facial paralysis for patients undergoing parotid tumor surgery.
How similar studies have performed: While this specific approach is novel, similar studies using advanced imaging techniques for surgical planning have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, PARIS
- Fondation A De Rothschild — Paris, Paris, France (Recruiting)
Study contacts
- Study coordinator: Amelie YAVCHITZ
- Email: ayavchitz@for.paris
- Phone: 0148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.