NCT03132727已完成不适用
Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Endoscopy
研究概览
简要总结
To determine if MRI can detect preoperative invasion of cartilage by laryngeal and hypopharyngeal carcinoma, and to compare it to CT imaging and histopathology in excised larynges and/or hypopharynges.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 ≥18 years old
- •Patient with a laryngeal or hypopharyngeal cancer at any stage
- •Patient eligible for a surgical treatment in multidisciplinary consultation
- •Patient who did not oppose its participation to the study
- •Indication for performing an MRI in addition to CT at the discretion of the investigator
排除标准
- •Patient with an ASA ("American Society of Anesthesiologists", international anesthesia classification) score ≥ 3,
- •Patient with a chirurgical contraindication
- •Patient with a MRI contraindication
- •Pregnant or nursing woman
- •Adult requiring protection (guardianship, supervision)
- •Patient participating in interventional research (Excluding physiological studies and interventional research involving only minimal risks and constraints that do not interfere with the analysis of the primary outcome).
结局指标
主要结局
Endoscopy
时间窗: 1-4 weeks
Tumor stage and cartilage invasion as determined by endoscopy : invaded/non invaded/undetermined
MRI
时间窗: 1-4 weeks
Tumor stage and cartilage invasion as determined by MRI : invaded/non invaded/undetermined
CT scan
时间窗: 1-4 weeks
Tumor stage and cartilage invasion as determined by CT scan : invaded/non invaded/undetermined
Anatomopathological analysis
时间窗: 2-4 weeks
Tumor stage and cartilage invasion as determined by histopathology in excised pieces : invaded/non invaded/undetermined
次要结局
未报告次要终点
研究者
研究点 (1)
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