INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- tumour visualization by means of c-MET targeted fluores-cence imaging
研究概览
简要总结
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.
详细描述
This is a single-center, non-randomized, prospective interventional pilot study. Feasibility of intraoperatively visualizing tumour (margins) in penile and tongue tumours using EMI-137 will be investigated. Patients, ≥ 18 years of age, with ≥T1 penile or tongue cancer undergoing primary tumour surgery will be included. All patients will receive an intravenous bolus injection of EMI-137 prior to surgery. Main study parameters/endpoints are: Intraoperative visualization of primary penile or tongue tumours using a dedicated clinical fluorescence camera. The in vivo detected fluorescence signal will be correlated to ex vivo measurements and pathological assessment of the ex-cised tissue.
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
- •Written informed consent, prior to performing any protocol related procedures.
- •Age ≥ 18 years at time of study entry.
- •≥ T1 penile or tongue squamous cell cancer
- •Scheduled for surgical primary tumour resection
排除标准
- •Involvement in the planning and/or conduct of the study.
- •Pregnant woman
- •Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days.
- •Severe kidney insufficiency
结局指标
主要结局
tumour visualization by means of c-MET targeted fluores-cence imaging
时间窗: peri-operative
The feasibility of intraoperative tumour visualization by means of c-MET targeted fluores-cence imaging will be evaluated, and the imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry.
次要结局
- Lymph node visualization by means of c-MET targeted fluores-cence imaging(peri-operative)
- Dysplasia or Cis by means of c-MET targeted fluores-cence imaging(Peri-operative)