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 |
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E.1.1.1 | Medical condition in easily understood language |
imaging of breast cancer with a fluorescent molecule |
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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 (on a preliminary series of 20 patients) of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to guide the surgeons during the surgery when they are performing tumorectomy of breast cancer.
Evaluation of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to show fluorescent “remaining in site” tumoral tissues after such tumorectomy (and how frequently it will happen) and analysis of their histopathological characteristics.
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E.2.2 | Secondary objectives of the trial |
Comparison to “historical” matched cases of the results of so performed tumorectomies. The following parameters will be analysed:
- Size of the tumorectomy pieces.
- Distances between margins and tumoral limits.
- Positivity of the margins.
- Delayed interventions for positive margins.
Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist
Evaluation of the ability of NIR fluorescence imaging camera device (after the intravenous injection of free ICG) to show fluorescent the sentinel lymph nodes of these patients among the axillary tissues and during their research, resection and (ex vivo and in vivo) analysis of the fluorescence ratios between the SLN and their surrounding fatty tissues
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection.
- Patients with tumorectomy foreseen after neo-adjuvant therapy will also be enrolled.
- Informed consent form signed.
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E.4 | Principal exclusion criteria |
- Diagnosis of mammary cancer established 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation (on a preliminary series of 20 patients) of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to guide the surgeons during the surgery when they are performing tumorectomy of breast cancer.
Evaluation of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to show fluorescent “remaining in site” tumoral tissues after such tumorectomy (and how frequently it will happen) and analysis of their histopathological characteristics.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After surgery and pathological analysis of the patient |
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E.5.2 | Secondary end point(s) |
Comparison to “historical” matched cases of the results of so performed tumorectomies. The following parameters will be analysed:
- Size of the tumorectomy pieces.
- Distances between margins and tumoral limits.
- Positivity of the margins.
- Delayed interventions for positive margins.
Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist
Evaluation of the ability of NIR fluorescence imaging camera device (after the intravenous injection of free ICG) to show fluorescent the sentinel lymph nodes of these patients among the axillary tissues and during their research, resection and (ex vivo and in vivo) analysis of the fluorescence ratios between the SLN and their surrounding fatty tissues
Evaluation of one prototype of probe dedicated to the ICG fluorescence detection but also coupled to a gamma probe. This prototype will be evaluated as a complementary way to identify the radioactive sentinel lymph nodes in our patients
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After surgery and pathological analysis of the patient |
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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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
comparison with previous cases without ICG |
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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
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After surgery and pathological analysis of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |