FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans (FLASH)- A Feasibility Dose Escalation Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Tracer detection
研究概览
简要总结
There is a need for better visualization of resection margins during surgery for soft tissue sarcoma. Optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in soft tissue sarcoma versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling soft tissue sarcoma visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age ≥ 18 years.
- •Patients with soft tissue sarcoma who are scheduled to undergo surgical intervention with curative intent
- •World Health Organization (WHO) performance score 0-
- •Signed written informed consent
排除标准
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- •Other invasive malignancy
- •Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause.
- •History of infusion reactions to bevacizumab or other monoclonal antibody therapies.
- •Inadequately controlled hypertension with or without current antihypertensive medications
- •Within 6 months prior to inclusion: myocardial infarction, Transient Ischemic Attack, Cerebral Vascular Accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
研究组 & 干预措施
Treatment group
Bevacizumab-IRDye800CW
干预措施: Bevacizumab-IRDye800CW (Drug)
结局指标
主要结局
Tracer detection
时间窗: up to 6 months
Determine if accumulation of the fluorescent tracer bevacizumab-800CW can be detected with an intraoperative near infrared camera system to identify soft tissue sarcoma tissue during surgery
次要结局
- Part 1: Dose finding(up to 6 months)
- Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 6 months)
- Part 2: Optimal dose(up to 6 months)
研究者
G.M. van Dam
Professor of Surgery, Principal Investigator
University Medical Center Groningen