ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jules Bordet Institute

Criteria

Inclusion Criteria:

• Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned.

• Informed Consent signed.

Exclusion Criteria:

• Diagnosis of breast cancer established by lumpectomy or "macro-biopsy".

• Operation after neo-adjuvant chemotherapy,

• Age less than 18 years.

• For pre-menopausal women, an operation planned for the second phase of their cycle.

• Inability to give informed consent.

• History of allergy or hypersensitivity to the investigational product, iodine.

• Clinical or biological hyperthyroidism.

• Known "toxic" thyroid nodules or known autonomous (hyperfunctional) thyroid.

• A reported pathological coronary artery disease.

• Creatinine > 1.5 mg / dl.

• During the 2 weeks before surgery, being on medications which are known to interfere with the ICG (ie anticonvulsants, heparin and haloperidol).

• Pregnancy or breast feeding period.