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

Free University of Brussels (ULB)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Indocyanine Green

Study type

Interventional

Funder types

Other

Identifiers

NCT02027818

BR-TUM-ICG-IV

Details and patient eligibility

About

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

Full description

In the operating room:

ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.

The surgeon will remove the tumour (and the axillary lymph nodes) as usual.

Optionally, peroperative "in vivo" imaging of the dissection of the tumour using the PDE camera will be performed.

In the Laboratory of Pathology:

The "fresh" tumorectomy piece will be processed as usual, and the thick sections for the evaluation of the margins as well as the tissues samples from each margins will be imaged using the PDE in comparison with the fluorescence in the mid part of the tumour and the fluorescent areas will be so delimited (and later analyzed in comparison with standards of known fluorescence intensity).

After fixation, the tumoral tissues will be thereafter processed "as usual".

If fluorescent foci are identified at the level of the axillary piece (in case of CALND), they will be dissected and processed as other lymph nodes. Additionally, metastatic lymph nodes -if present- will also be controlled for their microscopic fluorescence or not.

Using the near-infrared fluorescence microscope, the slides corresponding to the macroscopically fluorescent structures will be analyzed.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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