NCT04613349 FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
| NCT ID | NCT04613349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Parotid Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2021-01-13 |
| Primary Completion | 2027-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2021-01-13 with a primary completion date of 2027-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04613349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parotid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04613349 currently recruiting?
Yes, NCT04613349 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT04613349 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04613349 clinical trial?
NCT04613349 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The trial plans to enroll 88 participants.