Ultra-Violet Fluorescence Bronchial Cancer Location
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Histology of tissue
研究概览
简要总结
Diagnose lung cancer at an early stage is crucial for effective treatment. At these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light. These widely distributed autofluorescence methods detect early mucosal abnormalities. They are very sensitive but not specific to recognize the lung cancer. Thanks to European funding (EURIMUS), a new tool with fluorescent UV light has been developed.
The purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in Pneumology of this fluorescence method versus histological analysis of the tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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 affiliated or entitled to a social security scheme
- •Major Patient
- •Patient who signed the informed consent document
- •Patient with a known primary cancer in bronchial level
排除标准
- •Pregnant woman
- •Patient with a benign tumor histology
- •Patient with an unknown tumor histology.
研究组 & 干预措施
patients with lung cancer
干预措施: Biopsy (Other)
patients with lung cancer
干预措施: Rigid bronchoscopy with ultraviolet transmission (Procedure)
结局指标
主要结局
Histology of tissue
时间窗: Day 0
The histology give the final diagnosis
ultraviolet fluorescence ratio Iodine360 / Iodine450
时间窗: Day 0
Detection of cancerous tissues and healthy or inflammatory tissues is used to calculate the sensitivity and specificity of the rigid bronchoscopy with UV transmission compared to biopsy (gold standard).
次要结局
未报告次要终点