GREEN LIGHT: Intra-operative fluorescent imaging of sentinel lymph nodes in breast cancer - Green Light
- Conditions
- Breast cancer
- Registration Number
- EUCTR2008-007474-38-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
- Breast cancer patients planned to undergo a sentinel lymph node procedure.
- Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- history of allergy to iodine, shellfish, indocyanine green or human serum albumin.
- pregnancy
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method