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.

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2013-004496-12-BE
• Date of registration: 08/11/2013
• Prospective Registration: Yes
• Primary sponsor: Institut Jules Bordet
• Public title: 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.
• Scientific title: 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
• Date of first enrolment: 05/12/2013
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004496-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium

Contacts

• Name: Prof Pierre Bourgeois
• Affiliation: Institut Jules Bordet

• Name: Prof Pierre Bourgeois
• Affiliation: Institut Jules Bordet

Key inclusion & exclusion 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:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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

Primary Outcome(s)

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

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 Outcome(s)

Timepoint(s) of evaluation of this end point: after surgery and pathological analysis of the patient

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

Secondary ID(s)

BR-ICG-IV-NACT

Source(s) of Monetary Support

Institut Jules Bordet