Study of the macrocopic and microscopic distribution (after theintravenous injection) of one fluorescent marker (the Indocyanine Green)at the level of the mammary tumour, the axillary lymph nodes and thenormal mammary tissues of patients operated (mastectomy with completeaxillary node dissection) for breast carcinoma
- Conditions
- breast cancerTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2013-000100-41-BE
- Lead Sponsor
- Jules Bordet Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
- Patients with histo-pathological diagnosis of mammary cancer who are
candidate for mastectomy with complete axillary node dissection,
- Informed consent form signed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Diagnosis of mammary cancer established, either by tumorectomy, or
by gross biopsy,
- Operation foreseen after neo-adjuvant chemotherapy,
- Age less than18 years old.
- In pre-menopausal women, operation foreseen during the second
phase of their cycle,
- 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 dissemi-nated 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Definition of the histological distribution (in the vessels, in the<br>extravascular spaces, in specific cells) of IV injected ICG in the normal<br>and pathological tissues of tumour bearing breasts and in the axillary<br>nodes of these patients;Secondary Objective: Evaluation of the ability of NIR imaging to determine the tumoral<br>volume, specifically the « margins » of the tumoral tissues, to be<br>analyzed by the pathologist<br><br>Analysis of the correlation between ICG fluorescence and tumour<br>margins as defined at the microscopic level by the pathologist;Primary end point(s): Definition of the histological distribution (in the vessels, in the<br>extravascular spaces, in specific cells) of IV injected ICG in the normal<br>and pathological tissues of tumour bearing breasts and in the axillary<br>nodes of these patients;Timepoint(s) of evaluation of this end point: end of the study (10 patients investigated)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Evaluation of the ability of NIR imaging to determine the tumoral<br>volume, specifically the « margins » of the tumoral tissues, to be<br>analyzed by the pathologist<br><br>Analysis of the correlation between ICG fluorescence and tumour<br>margins as defined at the microscopic level by the pathologist;Timepoint(s) of evaluation of this end point: end of the study (10 patients investigated)