ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue. (EC2075)
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|ClinicalTrials.gov Identifier: NCT01993576|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : October 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer.||Drug: Indocyanine Green||Phase 1 Phase 2|
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).
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: indocyanine green
Indocyanine green is injected intravenously.
Drug: Indocyanine Green
Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery
Other Name: ICG
- Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma. [ 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.
- Microscopical detection of indocyanine green in breast tissue. [ 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993576
|Jules Bordet Insitute|
|Brussels, Belgium, B-1000|
|Study Chair:||Jean-Marie Nogaret, Prof.||Jules Bordet Institute|
|Study Chair:||Isabelle Veys, MD||Jules Bordet Institute|
|Study Chair:||Sophie VanKerckhove, biologist||Jules Bordet Institute|
|Study Chair:||Philippe De Neubourg, MD||Jules Bordet Institute|
|Study Chair:||Danielle Noterman, MD||Jules Bordet Institute|