E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
WOMAN WITH BREAST CANCER |
DONNE CON CARCINAMA MAMMARIO |
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E.1.1.1 | Medical condition in easily understood language |
WOMAN WITH BREAST CANCER |
DONNE CON CARCINAMA MAMMARIO |
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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 | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006206 |
E.1.2 | Term | Breast carcinoma NOS |
E.1.2 | System Organ Class | 100000004864 |
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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 |
Aim of the study is to assess the diagnostic performance of imaging obtained with new imaging methods represented by digital mammography (2D) with contrast medium (mdc) - DUAL ENERGY CONTRAST ENHANCED DIGITAL MAMMOGRAPHY - and Tomosynthesis (3D), in comparison of traditional 2D mammography and MRI with contrast medium (gold standard), in the follow-up of women operated for breast cancer, in order to assess the best diagnostic accuracy in the detection of recurrence. |
Lo studio mira alla valutazione della performance dell¿Imaging Diagnostico ottenuto con nuove metodiche rappresentate dalla mammografia digitale (2D) con mezzo di contrasto (mdc) - DUAL ENERGY CONTRAST ENHANCED DIGITAL MAMMOGRAPHY - e dalla TOMOSINTESI (3D), posto a confronto con l¿imaging tradizionale mammografico e con la RISONANZA MAGNETICA con mdc (gold standard), nel follow-up delle donne operate per carcinoma mammario, al fine di valutarne la migliore accuratezza diagnostica nella detezione di recidive ipsilateriali e/o controlaterali. |
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E.2.2 | Secondary objectives of the trial |
To standardize the examination protocol of Dual Energy Contrast Enhanced Digital Mammography with the drafting of new guidelines |
Standardizzazione del protocollo dell¿esame di Dual Energy Contrast Enhanced Digital Mammography (CEDM) con la redazione di nuove Linee Guida. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) female b) age> 18 years c) patients in follow-up for breast cancer d) breast recurrence suspicion by traditional imaging e) full information on the study and signed the informed consent to participation in the study f) execution of the exams at any time during the menstrual cycle g) estimated rate of glomerular filtration rate (eGFR)> 60 mL/min/1.73m2, derived from serum creatinine assay within two weeks prior to study entry
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a) Sesso femminile b) età > 18 anni c) pazienti in follow-up per carcinoma mammario d) sospetto di recidiva mammario all'imaging tradizionale e) piena informazione sullo studio e firma del consenso informato alla partecipazione allo studio f) esecuzione degli esami in qualsiasi momento del ciclo mestruale g) tasso stimato di filtrato glomerulare (eGFR) > 60 mL/min/1.73m2, derivato dal dosaggio di creatinina nel siero entro due settimane precedenti l'arruolamento nello studio
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E.4 | Principal exclusion criteria |
Absolute exclusion criteria a) presence of pacemakers or other devices in the chest wall b) inability to maintain an immobile position during the examination c) inflammatory skin diseases (psoriasis, eczema, etc.) d) pregnant or lactating e) the presence of tattoos on the affected area f) presence of piercing the nipple that cannot be removed g) internal/external devices that prevent the correct positioning of the patient h) metal / electronic, metal splinters i) the particular shape of the breast that prevents the execution of the examination (in particular breast too large) j) allergies to metals k) allergy to iodinated contrast and / or Gadolinium l) claustrophobia m) acute renal insufficiency of any severity due to the hepatorenal syndrome and / or settled in the pre-operative period for liver transplantation n) acute or chronic renal failure, moderate or severe (glomerular filtration rate <60 mL/min/1.73m2) o) the presence of breast implants
Criteria related exclusion a) micro-directed biopsy of ipsilateral breast within three months from the date of enrollment in the study b) needle aspiration in the ipsilateral breast within one month from the date of enrollment in the study c) oral contraceptives or hormonal treatment in the last 90 days d) d) the presence of open wounds or surgical clips |
Criteri di esclusione assoluti a) presenza di pacemakers o altri devices nella parete toracica b) incapacità a mantenere una posizione immobile durante l'esame c) malattie dermatologiche infiammatorie (psoriasi, eczema, ecc.) d) stato di gravidanza o allattamento e) presenza di tatuaggi sulla zona interessata f) presenza di piercing al capezzolo che non possono essere rimossi g) dispositivi interni/esterni che impediscono il corretto posizionamento della paziente h) impianti metallici/elettronici, schegge metalliche i) particolare conformazione della mammella che impedisce l'esecuzione dell'esame (in particolare mammella troppo grandi) j) allergie ai metalli k) allergie al mezzo di contrasto iodato e/o gadolini l) claustrofobia m) insufficienza renale acuta di qualsiasi gravità dovuta a sindrome epatorenale e/o stabilitasi nel periodo pre-operatorio al trapianto di fegato n) insufficienza renale acuta o cronica, moderata o grave (tasso di filtrazione glomerulare <60mL/min/1.73m2) o) presenza di protesi mammarie
Criteri di esclusione relativi p) micro-biopsia mirata nella mammella ipsilaterale entro tre mesi dalla data di arruolamento nello studio q) ago aspirato nella mammella ipsilaterale entro un mese dalla data di arruolamento nello studio r) cure ormonali o contraccettivi orali negli ultimi 90 giorni s) presenza di clips chirurgiche o ferite aperte
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Superiority of CEDM and combination of CEDM and 3D compared to 2D digital mammography traditional and synthesized. Standards of truth is the result of the histo-pathological examination.
2) Non-inferiority of the combination compared to CEDM and 3D contrast-enhanced MRI (DCE-MRI). Standards of truth is the result of the histo-pathological examination.
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1) Superiorità della CEDM e della combinazione di CEDM e 3D rispetto alla mammografia digitale 2D sintetizzata e tradizionale. Standard of truth è l’esito dell’esame cito/isto-patologico (Vedi sezione “Verifica cito/istologica”)
2) Non inferiorità della combinazione CEDM e 3D rispetto alla Risonanza Magnetica con mdc (DCE-MRI). Standard of truth è l’esito dell’esame cito/isto-patologico (Vedi sezione “Verifica cito/istologica”)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
every 12 months |
ogni 12 mesi |
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E.5.2 | Secondary end point(s) |
Success in the detection of ipsilateral and/or contralateral recurrences with CEDM, 3D/2D, DCE-MRI in order to assess the performance in terms of sensitivity and positive predictive value for the different proposed strategies. Standards of truth is the result of the histo-pathological examination.; Evaluation of the incremental effectiveness of the various proposed strategies. |
Successo nella evidenziazione delle recidive mammarie ipsilaterali e/o controlaterali con le metodiche CEDM, 3D/2D, DCE-MRI al fine di valutare la performance in termini di sensibilit¿ e valore predittivo positivo per le diverse strategie proposte. Standard of truth ¿ l¿esito dell¿esame cito/isto-patologico (Vedi sezione ¿Verifica cito/istologica¿); Valutazione del valore incrementale di efficacia delle diverse strategie proposte. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
every 12 months; every 12 months |
ogni 12 mesi; ogni 12 mesi |
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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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 |