E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Determination of the detection rate, false negative rate and overall accuracy of the sentinel lymph nodes approach using subcutaneous and peri-areolar injections of ICG for breast cancer patients. |
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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 |
Primary objectives:
- Determination of the detection rate, false negative rate and overall accuracy of the sentinel lymph nodes approach using subcutaneous and peri-areolar injections of ICG.
- These results will be compared to those with the (our) classical intra-mammary and peri-tumoral injections of 99mTc-HSA-Nanocolloids.
- Evaluation of their complementarity.
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E.2.2 | Secondary objectives of the trial |
- Evaluation of the time during which ICG will remain visible-detectable in women with tumorectomy at the level of the injections sites.
- In women with/after tumorectomy, study of the axillary liquids: frequency of the ICG detection in these liquids, duration of this detection, analysis of these liquids (ICG free and/or bound to proteins and/or cells,…)
- In women with tumorectomy, study of the immediate post-operative period modifications of the lymphatic drainage from the peri-areolar injected sites.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Female patients with cT2N0M0 unifocal breast cancer where SLN may be proposed.
- General operability.
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E.4 | Principal exclusion criteria |
- Age less than18 years old.
- Multifocal cancer
- Former operation in the axilla and/or breast.
- Any previous radiotherapy at the concerned breast and/or axilla and/or chest wall.
- Definite lymph node metastases.
- 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary objectives:
- Determination of the detection rate, false negative rate and overall accuracy of the sentinel lymph nodes approach using subcutaneous and peri-areolar injections of ICG.
- These results will be compared to those with the (our) classical intra-mammary and peri-tumoral injections of 99mTc-HSA-Nanocolloids.
- Evaluation of their complementarity.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Evaluation of the time during which ICG will remain visible-detectable in women with tumorectomy at the level of the injections sites.
- In women with/after tumorectomy, study of the axillary liquids: frequency of the ICG detection in these liquids, duration of this detection, analysis of these liquids (ICG free and/or bound to proteins and/or cells,…)
- In women with tumorectomy, study of the immediate post-operative period modifications of the lymphatic drainage from the peri-areolar injected sites.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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
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100 patients with cT2N0M0 unifocal breast cancer where SLN may be proposed will be monitered for SLN imaging. |
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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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |