ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue. (EC2075)

Free University of Brussels (ULB)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer.

Treatments

Drug: Indocyanine Green

Study type

Interventional

Funder types

Other

Identifiers

NCT01993576

2013-000100-41

Details and patient eligibility

About

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.

Full description

Primary objective:

Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent).

Secondary objectives:

Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.

Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).

Enrollment

10 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.