Jules Bordet Insitute
Brussels, Belgium, B-1000
NCT Number: NCT01993576
The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.
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Notify Me18 year–65 year
Female
Interventional
Phase 1 / Phase 2
Brussels, Belgium, B-1000
Primary objective:
Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent).
Secondary objectives:
Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.
Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery
Other names: ICG
Time frame: 10 months
Detecting of the fluorescence in between benign and malignant tissue by near infra-red imaging with a camera dictated to identify the margin of the tumor, and Histological detection of indocyanine green distribution in tumor bearing breasts and in axillary pieces of dissection and the detection of tumor cells in lymphe nodes.
Time frame: 10 months.
Detecting the fluorescence in between benign and malignant tissue by a microscope with a filter for near ifra-red at a good wave length of ICG.
Jules Bordet Institute
Other
Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
Acronym: EC2075
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