EUCTR2013-000100-41-BE
Active, not recruiting
Not Applicable
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
Conditionsbreast cancerTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
DrugsICG Pulsion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- breast cancer
- Sponsor
- Jules Bordet Institute
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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,
Outcomes
Primary Outcomes
Not specified
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