Intraoperative near-infrared fluorescence imaging of colorectal carcinoma with cRGD-ZW800-1 and dedicated imaging systems: A Phase II study - Phase 2 study with cRGD-ZW800-1

eids Universitair Medisch Centrum0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•1) Patients > 18 years old;
•2) Patients scheduled and eligible for resection because of colorectal
•carcinoma without any other clinically significant co-morbidity that can
•potentially jeopardize the patient well-being (judged by principal
•investigator);
•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.

•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) Patients with renal insufficiency (eGFR<60)
•4) Patients with a previous kidney transplantation in the medical history
•5) Immunocompromised patients who do not have the ability to respond normally
•to an infection due to an impaired on weakened immune system, caused by either
•a pre-existing disease or concomitant medications.
•6) Any condition that the investigator considers to be potentially jeopardizing
•the patients well-being or the study objectives.

发起方