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 I study

MCG0 个研究点目标入组 32 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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 suspicions of colorectal PM determined during the HIPEC meeting;
•3) Scheduled to undergo WL/FG-DLS in the UMCG as part of the standard preoperative work up for CRS and HIPEC;
•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 contraception during the trial and for 3 months thereafter.

•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 WL/FG-DLS confirmed by imaging (CT/PET);
•2) Has been injected with another Investigational Medicinal Product (IMP) within the past six months;
•3) Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 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 prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.

发起方

MCG