Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
Overview
- Phase
- Phase 1
- Intervention
- Indocyanine Green
- Conditions
- Breast Cancer.
- Sponsor
- Jules Bordet Institute
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned.
- •Informed Consent signed.
Exclusion Criteria
- •Diagnosis of breast cancer established by lumpectomy or "macro-biopsy".
- •Operation after neo-adjuvant chemotherapy,
- •Age less than 18 years.
- •For pre-menopausal women, an operation planned for the second phase of their cycle.
- •Inability to give informed consent.
- •History of allergy or hypersensitivity to the investigational product, iodine.
- •Clinical or biological hyperthyroidism.
- •Known "toxic" thyroid nodules or known autonomous (hyperfunctional) thyroid.
- •A reported pathological coronary artery disease.
- •Creatinine \> 1.5 mg / dl.
Arms & Interventions
indocyanine green
Indocyanine green is injected intravenously.
Intervention: Indocyanine Green
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Microscopical detection of indocyanine green in breast tissue.(10 months.)