E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
breast cancer |
cancer mammaire |
|
E.1.1.1 | Medical condition in easily understood language |
Mammary cancer |
cancer mammaire |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with histo-pathological diagnosis of mammary cancer who are
candidate for mastectomy with complete axillary node dissection,
- Informed consent form signed. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
end of the study (10 patients investigated) |
|
E.5.2 | 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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
end of the study (10 patients investigated) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
10 patients who will undergo mastectomy for breast cancer will be
enrolled, the last one being expected to be enrolled before 1/01/2014 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |