Intraoperative near-infrared fluorescence imaging of colorectal carcinoma with cRGD-ZW800-1 and dedicated imaging systems: A Phase II study
- Conditions
- Colorectal carcinoma
- Registration Number
- NL-OMON22876
- Lead Sponsor
- eiden University Medical Center, Leiden, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
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.
Patients will be excluded if any of the criteria below apply:
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems
- Secondary Outcome Measures
Name Time Method To define the optimal dose of cRGD-ZW800-1 for intraoperative near-infrared fluorescence imaging of tumors.