NL-OMON50658
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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