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.

Study of the (intravenously injected) ICG distribution in tumour bearing breasts and in axillary pieces of dissection of patients who have received neo-adjuvant therapy for histologically proven mammary cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004496-12-BE

Enrollment

Registered

2013-11-08

Start date

2013-12-05

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

imaging of tumours and their margins after intravenous injection of Indocyanine Green to breast cancer patients

Interventions

Trade Name: Indocyanine Green Pulsion 25mg Pharmaceutical Form: Powder for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the ability of NIR imaging to determine the tumoral volume, the tumoral tissues to be analyzed by the pathologist;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 - Analysis of the correlation between 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 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	—

Measure

Time frame

Main Objective: Evaluation of the ability of NIR imaging to determine the tumoral volume, the tumoral tissues to be analyzed by the pathologist;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 - Analysis of the correlation between 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 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

Measure	Time frame
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 - 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: after surgery and pathological analysis of the patient	—

Measure

Time frame

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 - 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: after surgery and pathological analysis of the patient

—

Countries

Belgium

Contacts

Public ContactProf Pierre Bourgeois

Institut Jules Bordet

pierre.bourgeois@bordet.be003225413276

Outcome results

None listed

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