Study evaluating breast cancer tumorectomy guided by Near-Infrared imaging after the intravenous injection of free Indocyanine Green

Jules Bordet Institute0 sitesSeptember 10, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Imaging of tumours and their margins after intravenous injection ofIndocyanine Green to breast cancer patients
Sponsor: Jules Bordet Institute
Status: Active, not recruiting
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

September 10, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•\- 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