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

Phase 2

Recruiting

Conditions: Cancer
Malignant tumors
10027655

Registration Number: NL-OMON50658

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 18

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;
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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br>To determine the sensitivity of NIR fluorescence imaging with cRGD-ZW800-1</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br>To define the optimal dose of cRGD-ZW800-1 for intraoperative near-infrared<br /><br>fluorescence imaging of tumors.<br /><br>To assess safety and tolerability of single doses of cRGD-ZW800-1.</p><br>