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

eiden University Medical Center0 sites12 target enrollmentAugust 9, 2017

Overview

No summary available.

Registry

who.int

Start Date

August 9, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

eiden University Medical Center

•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

•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.