Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer

Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)

This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.

Visits:

Screening:

Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month.

Intervention:

In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).

The search or sentinel node will be made using a infrared camera for transcutaneous visualization Secondly, data lymphoscintigraphy may be communicated to the surgeon. The nodes are identified as SN fluorescent nodes and / or radioactive nodes.

• All radioactive nodes and / or fluorescent will be deleted
• Reports of anatomy fluorescent SN and / or hot

Next visit:

The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.

Inclusion Criteria:

1. Female age > 18 years
2. Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
3. Diagnosis confirmed by biopsy
4. Breast cancer extended in situ
5. First surgical treatment

Exclusion Criteria:

1. Neoadjuvant chemotherapy or hormone therapy.
2. Multicentric tumor
3. Pregnant patient
4. Ongoing participation in another clinical trial with an investigational drug