Parotid Tumor Clinical Trial
— NEFAPAOfficial title:
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
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.
Status | Recruiting |
Enrollment | 88 |
Est. completion date | May 13, 2025 |
Est. primary completion date | January 13, 2025 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
France | Fondation A De Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04104802 -
Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors
|
||
Completed |
NCT05152056 -
MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors
|
||
Recruiting |
NCT04028479 -
The Registry of Oncology Outcomes Associated With Testing and Treatment
|
||
Recruiting |
NCT03950323 -
Intra-parotid Facial Nerve Tractography
|
N/A | |
Not yet recruiting |
NCT05401370 -
Role of Methylene Blue in Parotid Surgery
|
N/A | |
Completed |
NCT01414790 -
The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome
|
Phase 3 | |
Completed |
NCT04803032 -
Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy
|
N/A |