Study of the ICG Distribution in Breast Tumours or in Axillary Lymph Nodes of Patients After Neoadjuvant Therapy

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after neoadjuvant therapy (chemo- or hormonotherapy)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jules Bordet Institute

Criteria

Inclusion Criteria:

• Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,

• Informed consent form signed.

Exclusion Criteria:

• Diagnosis of mammary cancer established, either by tumorectomy, or by "gross" biopsy,

• Age less than18 years old.

• Inability to give informed consent.

• History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.

• Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.

• Documented coronary disease.

• Advanced renal impairment (creatinine > 1,5mg/dl).

• During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).

• Pregnancy, breastfeeding