Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy in Patients With a Pulmonary Lesion Considered to be Malignant - DEFLECT I
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fluorescent signal of malignant lesion versus non-tumorous tissue.
研究概览
简要总结
In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and/or lymph nodes considered to be malignant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Signed informed consent prior to participation in the study.
- •Age ≥ 18 years.
- •Patient has at least one intrabronchial, near-to-airway located or peripheral pulmonary nodule - with or without pathological lymph nodes - which is considered malignant (independent of its primary origin).
- •Patient is considered fit to undergo a diagnostic and/or therapeutic bronchoscopy (with or without addition of virtual navigation and/or endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated) to obtain tumor material according to standard care protocols.
排除标准
- •History of infusion reactions to bevacizumab.
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- •Pregnancy or breast feeding.
结局指标
主要结局
Fluorescent signal of malignant lesion versus non-tumorous tissue.
时间窗: Assessed directly during the bronchoscopy procedure
Comparison of the in vivo fluorescent signal of malignant lesion (pulmonary nodule or lymph node metastasis) versus non-tumorous tissue: The fluorescent signal will be assessed qualitatively (categorical data) and quantitatively (pulmonary nodule: by multi-diameter single fiber reflectance spectroscopy/single-fiber fluorescence spectroscopy (MDSFR/SFF), lymph node metastases: by ultrasound guided needle biopsy single-fiber fluorescence (USNB/SFF)).
次要结局
- Optimal dose of bevacizumab-800CW(Up to 1 year)
- FLuorescence signal analyses(Up to 1 year)
- Safety of bevacizumab-800CW injection and fluorescence molecular imaging(Up to 24 hours after the fluorescence molecular bronchoscopy)