EUCTR2017-002772-60-NL进行中(未招募)1 期
Intraoperative near-infrared fluorescence imaging of colorectal carcinoma with cRGD-ZW800-1 and dedicated imaging systems: A Phase II study
eiden University Medical Center0 个研究点目标入组 12 人开始时间: 2017年8月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 12
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
- •1) Patients > 18 years old;
- •2) Patients scheduled and eligible for resection because of colorectal carcinoma;
- •3) Patients should be capable and willing to give informed consent before study specific procedures;
- •4) Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant;
- •5) The patient has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening;
- •6) Absence 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.
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1) History of a clinically significant allergy or anaphylactic reactions;
- •2) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- •3) 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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