Study of the possibility to visualize and define margins of breast tumours with a near-infrared camera thanks to the IV injection of Indocyanine Green, a fluorescent molecule.

• 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: EUCTR2013-004496-12-BE
• Lead Sponsor: Institut Jules Bordet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-08
• Last Update Posted: 7 October 2014

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 have received neo-adjuvant therapy and are candidate, either for tumorectomy, or 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 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, either by tumorectomy, or 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 determine the tumoral volume, the tumoral tissues to be analyzed by the pathologist;Primary end point(s): - Evaluation of the ability of NIR imaging to determine the tumoral volume, the tumoral tissues to be analyzed by the pathologist;Timepoint(s) of evaluation of this end point: after surgery and pathological analysis of the patient;Secondary Objective: - Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (viable ones, necrotic ones and scars”) of tumour bearing breasts and in the axillary nodes of patients who have received neo-adjuvant treatment for histologically proven breast cancer<br>- Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (viable ones, necrotic ones and scars”) of tumour bearing breasts and in the axillary nodes of patients who have received neo-adjuvant treatment for histologically proven breast cancer<br>- Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist<br>;Timepoint(s) of evaluation of this end point: after surgery and pathological analysis of the patient