ear-infrared fluorescence imaging with cRGD-ZW800-1 in patients with colorectal carcinoma

Phase 1

• Conditions: The trial will be conducted in patients with malignant tumors, and is intended to localize cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002772-60-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-09
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

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

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 clinical trial of medicinal product
• Study Design: Not specified