The trial will be conducted in patients with malignant tumors, and is intended to localize cancer.
Conditions
Interventions
Product Name: cRGD-ZW800-1
Product Code: cRGD-ZW800-1
Pharmaceutical Form: Solution for injection
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
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) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems ;Secondary Objective: 1) To define the optimal dose of cRGD-ZW800-1 for intraoperative near-infrared fluorescence imaging of tumors. 2) To assess safety and tolerability of single doses of cRGD-ZW800-1. ;Primary end point(s): To determine the sensitivity of NIR fluorescence imaging with cRGD-ZW800-1;Timepoint(s) of evaluation of this end point: Surgery and Follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To define the optimal dose of cRGD-ZW800-1 for intraoperative near-infrared fluorescence imaging of tumors. To assess safety and tolerability of single doses of cRGD-ZW800-1. ;Timepoint(s) of evaluation of this end point: Follow-up | — |
Countries
Netherlands
Contacts
Public ContactA.L. Vahrmeijer
Leiden University Medical Center
Outcome results
None listed