NL-OMON54735招募中2 期
FLUOPANC-trial - Intraoperative near-infrared fluorescence imaging in pancreatic- and extrahepatic bile duct tumors using cRGD-ZW800-1 and dedicated imaging systems: A phase II feasibility, dose-ranging and optimal dose-(interval) selection trial - FLUOPANC-trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients >18 years old;
- •- Patients scheduled and eligible for open/robotic resection because of
- •(histologically proven) pancreatic carcinoma with or without neoadjuvant
- •treatment. As well as patients scheduled and eligible for resection because of
- •(histologically proven) distal or perihilar cholangiocarcinoma with or without
- •neoadjuvant treatment.
- •- All women of childbearing potential and all males must practice effective
- •contraception during the study and be willing and able to continue
- •contraception for at least 30 days after their last dose of study treatment.
- •- Patients should be capable and willing to give informed consent before study
- •specific procedures;
排除标准
- •- History of a clinically significant allergy or anaphylactic reactions;
- •- Patients with renal insufficiency (eGFR<60 ml/min/1,73 m2);
- •- Patients with a previous kidney transplantation in the medical history;
- •- Pregnant women, or women giving breast feeding;
- •- Patients who are immunocompromised and do not have the ability to respond
- •normally to an infection due to an impaired or weakened immune system, caused
- •by either a pre-existing disease or concomitant medications (excluding intended
- •neoadjuvant treatment);
- •- Presence of any psychological, familial, sociological or geographical
- •condition potentially hampering compliance with the study protocol and
- •follow-up schedule; those conditions should be discussed with the patient
- •before registration in the trial;
- •- Any condition that the investigator considers to be potentially jeopardizing
- •the patients well-being or the study objectives.
研究者
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