Feasibility of fluorescence imaging with bevacizumab-800CW during bronchoscopy in patients with a pulmonary lesion considered to be malignant - DFLECT I
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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)).
研究概览
简要总结
To assess the feasibility of fluorescence molecular imaging with bevacizumab-800CW during bronchoscopy for identification of malignant pulmonary lesions and/or pathological lymph nodes.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 or other monoclonal antibodies according to the patient’s medical history
- •Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
- •Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause) on the day of tracer administration.
结局指标
主要结局
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)).
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
- Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology result.
- Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios.
- Assessment of safety of bevacizumab-800CW injection and procedures in relation with fluorescent molecular imaging through summaries of adverse events, including data on the additional time (in minutes) needed for in vivo qualitative and quantitative assessment of the fluorescent signal. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0.
研究者
Frederike Bensch
Scientific
Universitair Medisch Centrum Groningen