ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study

Inclusion Criteria: 1. female; 2. age of ≥18 years; 3. histological diagnosis of ductal invasive breast cancer; 4. 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; 5. ECOG Performance Status (PS) 0 or 1; 6. signed informed consent form (ICF) obtained prior to any study related procedure. Exclusion Criteria: 1. advanced invasive breast cancer (cT3 and/or cT4); 2. in situ breast cancer disease; 3. lobular invasive breast cancer (at histology); 4. invasive breast cancer treated by neoadjuvant chemotherapy and/or endocrine therapy; 5. prior history of invasive or breast cancer of the actually affected breast in the past; 6. history of allergy or hypersensitivity to investigational product (active substance or ingredients); 7. history of allergy to iodine or to shellfish; 8. have apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal, or disseminated autonomy of the thyroid gland; 9. documented coronary disease 10. advanced renal insufficiency (serum creatinine \>1.5 mg/dL); 11. chronic liver disease with the Child-Pugh class B or C ; 12. concurrent medication which reduces or increases the elimination of indocyanine green dye (ie, anticonvulsants, haloperidol, and heparin) during the 2 weeks before the expected operation; 13. pregnant or lactating women; 14. inability to give informed consent.