Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment.
Two preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm.
In the first time frame (intraoperative arms), the dose of, respectively 0.125 mg/kg and 0.25 mg/kg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups.
In the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg/kg, 1 mg/kg, and 2 mg/kg of ICG will be administered 24 h before surgery in 3 subgroups.
female;
age of ≥18 years;
histological diagnosis of ductal invasive breast cancer;
a primary early-stage invasive breast cancer (cT1 and/or cT2, assessed clinically and/or radiologically), without prior BC surgery of the actually affected breast;
advanced invasive breast cancer (cT3 and/or cT4);
in situ breast cancer disease;
lobular invasive breast cancer (at histology);
invasive breast cancer treated by neoadjuvant chemotherapy and/or endocrine therapy;
Parallel
Indocyanine green
DrugIndocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter: * at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or * in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).
Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins at the patient level
The sensitivity (Se), specificity (Sp), negative predictive value (NPV), false negative rate (FNR), FPR of the ICG-FI technique will be computed at the patient level
Comparison of ICG-FI technique accuracy at different doses and timing
The sensitivity (Se), specificity (Sp), negative predictive value (NPV), false negative rate (FNR), FPR of the ICG-FI technique will be computed
Characterization of the breast tumor fluorescence (tumor-to- background fluorescence ratio)
Characterization of the appearance and intensity of fluorescence at the level of tumor cells
Evaluation of fluorescence intensity of axillary lymph nodes
The distribution of fluorescence intensity will be calculated depending on the type of axillary lymph node (LN) : sentinel vs other and respectively metastatic LN vs healthy LN)
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