EUCTR2021-006700-32-NL进行中（未招募）1 期
A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using submucosal bevacizumab-800CW. - IBIZA-1(pilot)
Meander Medical Centre0 个研究点目标入组 5 人开始时间: 2022年7月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Oral and written informed consent (IC)
- •- Aged 18 years and older
- •- Pathologically confirmed and/or suspected cT1-3N0-2M0 colon carcinoma
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •- Distant metastasis
- •- Suspicion of cT4 disease based on pre-operative assessment
- •- Metastatic or T4 disease discovered during intraoperative staging
- •- Pregnancy, lactation or a planned pregnancy during the course of the
- •- Previous colon surgery, excluding appendectomy.
- •- Contra-indication for laparoscopic/robotic surgery
- •- Inadequately controlled hypertension with or without current antihypertensive medication.
- •- Within 6 months prior to inclusion: myocardial infarction, TIA, CVA, pulmonary embolism, unstable angina pectoris, or uncontrolled chronic hepatic failure.
- •- Regarding bevacizumab: Hypersensitivity to Chinese Hamster Ovary
- •(CHO) cell products or other recombinant human or humanised
- •antibodies. Or an allergy for its components (Trehalose dehydrate,
- •sodium phosphate, polysorbate 20, water for injections)
研究者
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