Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy

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

Summary

We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent

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

Details

• Lead Sponsor: Jules Bordet Institute

Criteria

Inclusion Criteria:

• Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection,

• Informed consent form signed.

Exclusion Criteria:

• Diagnosis of mammary cancer established 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