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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
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).
Hôpital Européen Georges Pompidou
Paris, France
The primary endpoint is the SN detection rate during surgery by fluorescence, by isotopes, by combining the two. The detection rate is defined by the number of patient
The detection rate is defined by the number of patient who at least one axillary sentinel node detected by fluorescence and / or isotope intraoperatively / number of female patients injected.
Time frame: During surgery
The time between the incision and removal of the first sentinel node identified
Time frame: During surgery
The sensitivity of indocyanine green compared to the technical reference ( percentage of nodes detected by the isotope and which are also detected by the indocyanine green )
Time frame: During surgery
The wrong negative rate (number of female patients in whom at least one metastatic sentinel node has been detected by isotope and not by ICG)
Time frame: During surgery
Technical direct cost
Time frame: during the study
Incidence rates of allergic reactions
Time frame: From screening till 1 month after the surgery
Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )
Time frame: From screening till 1 month after the surgery
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