NCT04613349招募中不适用
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
研究概览
简要总结
- 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).
- nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI.
- rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
时间窗: day 0
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
assessment by the surgeon during the excision surgery of the parotid lesion
时间窗: day 0
assessment by the surgeon during the excision surgery of the parotid lesion
次要结局
未报告次要终点
研究者
研究点 (2)
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