Study of the macrocopic and microscopic distribution (after the intravenous injection) of one fluorescent marker (the Indocyanine Green) at the level of the mammary tumour, the axillary lymph nodes and the normal mammary tissues of patients operated (mastectomy with complete axillary node dissection) for breast carcinoma

Histological study of the (intravenously injected) Indocyanine Green (ICG) distribution in tumour bearing breasts and in axillary pieces of dissection - Histological distribution of ICG in tumor bearing breast and CALND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000100-41-BE

Enrollment

Registered

2013-02-01

Start date

2013-02-28

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Trade Name: ICG Pulsion Pharmaceutical Form: Powder for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Main 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 of tumour bearing breasts and in the axillary nodes of these patients;Secondary Objective: Evaluation of the ability of NIR imaging to determine the tumoral volume, specifically the « margins » of the tumoral tissues, to be analyzed by the pathologist Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist;Primary 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 of tumour bearing breasts and in the axillary nodes of these patients;Timepoint(s) of evaluation of this end point: end of the study (10 patients investigated)	—

Measure

Time frame

Main 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 of tumour bearing breasts and in the axillary nodes of these patients;Secondary Objective: Evaluation of the ability of NIR imaging to determine the tumoral volume, specifically the « margins » of the tumoral tissues, to be analyzed by the pathologist Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist;Primary 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 of tumour bearing breasts and in the axillary nodes of these patients;Timepoint(s) of evaluation of this end point: end of the study (10 patients investigated)

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Secondary

Measure	Time frame
Secondary end point(s): Evaluation of the ability of NIR imaging to determine the tumoral volume, specifically the « margins » of the tumoral tissues, to be analyzed by the pathologist Analysis of the correlation between ICG fluorescence and tumour 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)	—

Measure

Time frame

Secondary end point(s): Evaluation of the ability of NIR imaging to determine the tumoral volume, specifically the « margins » of the tumoral tissues, to be analyzed by the pathologist Analysis of the correlation between ICG fluorescence and tumour 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)

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Countries

Belgium

Contacts

Public ContactProf.

Jules Bordet Institute

pierre.bourgeois@bordet.be003225413276

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026