Study of the distribution of a near-infrared fluorescent molecule in the limits of breast tumors after intravenous injectio

Conditions: Imaging of tumours and their margins after intravenous injection of Indocyanine Green to breast cancer patients
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-005178-23-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

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.

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the ability of NIR imaging to show (fluorescent) the tumoral volumes, the tumoral tissues to be analyzed by the pathologist, especially at the level of the operative margins;Secondary Objective: Analysis of the correlation between (levels of) ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist;Primary end point(s): Evaluation of the ability of NIR imaging to show (fluorescent) the tumoral volumes, the tumoral tissues to be analyzed by the pathologist, especially at the level of the operative margins;Timepoint(s) of evaluation of this end point: After surgery and pathological analysis of the patient

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Analysis of the correlation between (levels of) ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist;Timepoint(s) of evaluation of this end point: After surgery and pathological analysis of the patient