Clinical trial · Observational
Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors
NCT04104802CI-TRIAL-00043613FACPARwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): refusal of the ansm
Summary
Brief summary (as posted)
Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parotid Tumor | Parotid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the sensitivity of a high-resolution 3 Tesla MRI with gadolinium injection with specific sequences versus intraoperative findings of the surgeon (gold standard), to evaluate the anatomic relationships between parotid tumor and facial nerve.
- timeFrame
- 1 day
- description
- Sensitivity of new MRI sequences to determine whether the parotid tumor is in contact or at a distance from the facial nerve (common core and first division branches) in comparison with the intra-operative examination (gold standard). The contact between the parotid tumor and the trunk of the facial nerve or its first branches of division is a binary qualitative variable with modalities defined as: * "Yes": tumor on contact (distance between the tumor and the trunk of the facial nerve or its first branches between 0 and 5 mm) * "No": trunk of the facial nerve or its first divisional branches located at a distance (ie more than 5mm from the parotid tumor).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient over 18 years old * Patient seeking first-line surgery for a parotid tumor (single or multiple, benign or malignant) * Parotidian tumor located near the trunk of the facial nerve and / or its first division branches (temporofacial and cervicofacial), during a clinical evaluation performed by the surgeon in preoperative consultation * Patient affiliated or beneficiary of a social security scheme * Written consent to participate in the study Exclusion Criteria: * Personal history of ipsilateral parotid surgery * Contraindication to MRI (electronic device, metallic foreign body, claustrophobia) * Known hypersensitivity to gadolinium contrast agents * Renal impairment known: glomerular filtration rate \<30 mL / min * Pre or post-operative period of liver transplantation * Patient benefiting from a legal protection measure * Pregnant or lactating woman
References
Publications (0)
Data not yet available
No reference posted for this study.