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

Summary

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.

Eligibility

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.

Conditions2

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