No registrations found.
ID
Source
Brief title
Health condition
Colorectal carcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems
Secondary outcome
To define the optimal dose of cRGD-ZW800-1 for intraoperative near-infrared fluorescence imaging of tumors.
Background summary
Surgery remains the primary treatment for colorectal cancer where complete removal of all malignant tissue is the cornerstone of curative intended oncologic surgery. However, discriminating between malignant and benign tissue can be challenging, especially after neoadjuvant treatment. Near-infrared fluorescence imaging with cRGD-ZW800-1 can provide accurate and real-time visualization of tumors during surgery.
Study objective
Real-time visualization of colorectal carcinoma during surgery with fluorescence
Study design
-
Intervention
cRGD-ZW800-1 injection prior to surgery
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.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7724 |
| Other | METC LUMC : P17.242 |