E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
BREAST CANCER |
Carcinoma della Mammella |
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E.1.1.1 | Medical condition in easily understood language |
BREAST CANCER |
Carcinoma della Mammella |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
validation of new method, the fluorescence lymphography by comparison with the gold standard method, the radio colloid |
- validazione della nuova metodica, la linfografia a fluorescenza, mediante il confronto diretto con il metodo gold standard, il radio colloide. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age ≥ 18 years; - Cytologically or histologically diagnosis of breast cancer; - Primary tumor with a diameter ≤ 3 cm; - Negative clinical evaluation of axilla; - Signed Informed Consent. |
Eta' ≥ 18 anni; - Diagnosi citologicamente o istologicamente accertata di carcinoma mammario; - Tumore primitivo inferiore o uguale a 3 cm di diametro; - Ascella clinicamente negativa; - Firma del Consenso Informato. |
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E.4 | Principal exclusion criteria |
- Hypersensitivity / known allergy to ICG, sodium iodide or iodine; - Hyperthyroidism; - Thyroid carcinoma; - Pregnancy and / or lactation; - Taking drugs that affect liver function; - Renal failure; - Taking medications that can alter the absorption of indocyanine-green; - Psychiatric disorders or any disease that compromises the ability to provide informed consent for participation in this study. |
Ipersensibilita'/allergia nota al ICG, allo ioduro di sodio o allo iodio; - Ipertiroidismo; - Neoplasia tiroidea; - Gravidanza e/o allattamento; - Assunzione di medicinali che influenzano la funzionalita' epatica; - Insufficienza renale; - Assunzione di farmaci che possono alterare l’assorbimento del Verde -Indocianina ; - Malattie psichiatriche o qualsiasi malattia, che compromette la capacita' di fornire il consenso informato per la partecipazione a questo studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Validation of the new method, the fluorescence lymphography, by direct comparison with the gold standard method, the radio colloid. It will be calculated the Predictive Positive Value as the LS identified percentage both through ICG and gold standard on the LS value identified through ICG . We will calculated the new diagnostic approach Sensitivity ICG as the percentage of LS identified both through ICG and gold standard on the LS value identified through gold standard . |
- Validazione della nuova metodica, la linfografia a fluorescenza, mediante il confronto diretto con il metodo gold standard, il radio colloide. Verra' calcolato il Valore Predittivo Positivo (VPP) come la percentuale dei LS individuati sia tramite ICG che tramite gold standard sul totale dei LS individuati tramite ICG Calcoleremo anche la Sensibilita' del nuovo approccio diagnostico ICG come la percentuale di LS individuati sia tramite ICG che tramite gold standard sul totale dei LS individuati tramite gold standard . |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after the histological evaluation of the linfonodes |
dopo la valutazione istologica deli linfonodi asportati |
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E.5.2 | Secondary end point(s) |
|
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 | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Yes |
E.8.2.3.1 | Comparator description |
procedura diagnostica standard |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |