NL-OMON51885尚未招募不适用
Detection of tumor tissue in peritoneal metastases of colorectal origin using a VEGF targeted optical fluorescent imaging tracer during diagnostic laparoscopy: a single center phase 1 study - SELECT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1) Age >= 18 years;
- •2) Patients with colorectal PM;
- •3) Scheduled to undergo CRS+HIPEC in the UMCG as part of standard care for
- •colorectal PM;
- •4) WHO performance score of 0-2;
- •5) Mentally competent person who is able and willing to comply with study
- •procedures;
- •6) Signed written informed consent;
- •7) For female subjects who are of childbearing potential, are premenopausal
- •with intact reproductive organs or are less than two years post-menopausal:
- •- A negative serum pregnancy test prior to receiving the tracer.
- •- Willing to ensure that she or her partner used effective birth control during
- •the trial and for three months thereafter.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1) Clinically advanced stage of colorectal PM, not suitable for CRS+HIPEC
- •confirmed by imaging (CT/PET);
- •2) Has been injected with another Investigational Medicinal Product (IMP)
- •within the past month;
- •3) Concomitant malignancies, except for adequately treated basocellular
- •carcinoma of the skin or in situ
- •carcinoma of the cervix uteri. Subjects with prior malignancies must be
- •disease-free for at least five years.
- •4) Clinically significant (i.e. active) cardiac disease (e.g. congestive heart
- •failure, symptomatic coronary artery disease and cardiac dysrhythmia) or
- •myocardial infarction within 12 months prior to enrolment;
- •5) Significant renal (creatinine>110µmol/L) dysfunction;
- •6) Previous allergic reaction to Bevacizumab;
- •7) Medical or psychiatric conditions that compromise the patient*s ability to
- •give informed consent;
- •8) Pregnancy or breast feeding;
- •9) Any significant change in their regular subscribed or not-subscribed
- •medication 14 days before tracer administration
研究者
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