E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
imaging of tumours and their margins after intravenous injection of Indocyanine Green to breast cancer patients |
|
E.1.1.1 | Medical condition in easily understood language |
new imaging of breast cancer with a fluorescent molecule |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
Evaluation of the ability of NIR imaging to determine the tumoral volume, the tumoral tissues to be analyzed by the pathologist |
|
E.2.2 | Secondary objectives 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 (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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after surgery and pathological analysis of the patient |
|
E.5.2 | 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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
after surgery and pathological analysis of the patient |
|
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
|
after surgery and pathological analysis of the last patient |
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | |