Study to see if it is possible to guide tumorectomy in case of breast cancer by near-infrared fluorescence after intravenous injection of Indocyanine Gree
- Conditions
- Imaging of tumours and their margins after intravenous injection ofIndocyanine Green to breast cancer patientsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003268-19-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 histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection.
- Patients with tumorectomy foreseen after neo-adjuvant therapy will also be enrolled.
- 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 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method