E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast cancer |
Tumore mammario |
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E.1.1.1 | Medical condition in easily understood language |
Breast cancer |
Tumore 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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012992 |
E.1.2 | Term | Digital mammography |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
non-inferiority of CESM versus the combination of FFDM, US and versus MRI in breast lesions detection and characterisation during pre-surgical evaluation of women with dense breasts. |
Studio di non inferiorità della metodica CESM verso la combinazione di FFDM, US ed RM nella ricerca e caratterizzazione di lesioni mammarie nelle donne con seno denso, durante la valutazione prechirurgica. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of detection and characterisation with CESM of breast lesions silent to FFDM but visible with MRI or US. Evaluation in women with dense breasts of CESM assessment method versus the combination of FFDM, US and versus MRI in detection and characterisation of breast lesions, especially for multifocality. CESM sensitivity and specificity comparison versus others imaging methods in multifocal lesions study. |
Valutazione della rilevazione e caratterizzazione con CESM di lesioni silenti alla mammografia tradizionale, ma visibili e non con RM o con US. Valutazione della metodica CESM verso la combinazione di FFDM, US ed RM nella ricerca e caratterizzazione di lesioni mammarie, in particolare delle lesioni multifocali, nelle donne con seno denso. Confronto della sensibilità e della specificità di CESM rispetto alle altre metodiche diagnostiche nello studio delle lesioni multifocali. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Woman diagnosed with breast cancer from FFDM and/or US imaging and for whom a pre-surgical evaluation of extent of disease (including multi-focality) is recommended 2. The subject has dense breasts (BIRADS class 3 or 4 on FFDM) 3. Capable and willing to comply with study procedures, and having signed and dated the informed consent form 4. The subject must have a breast size compatible with the dimensions of the image detector 5. The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations |
1. Donne con una diagnosi di tumore al seno che sia stata ottenuta con FFDM e/o con esame ecografico, per cui sia prevista la valutazione prechirurgica dell’estensione di malattia (multifocalità inclusa) 2. Donne con seno mammograficamente denso (BI-RADS 3 o 4 alla FFDM) 3. Donne in grado di intendere e di volere che abbiano manifestato la loro volontà di partecipare allo studio mediante consenso informato scritto firmato e datato e possano rispettare le procedure dello studio. 4. La paziente deve avere il seno di una taglia compatibile con le dimensioni del detettore di imagine. 5. Il soggetto deve essere in condizioni di salute sufficientemente buone da poter essere sottoposto alle cure standard ad agli esami CESM. |
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E.4 | Principal exclusion criteria |
1. The subject is known to have risks of adverse effects with iodine contrast agents. 2. The subject is asymptomatic and without suspicious findings from routine imaging. 3. The subject has BI-RADS 1, 2 breast density class evaluation from latest mammography. 4. The subject has been previously included in this study. 5. The subject has breasts too large to be adequately positioned on FFDM digital receptor without anatomical cut off during an FFDM examination. 6. The subject is participating in, or has participated (within the prior 30 days) in another clinical trial whit drugs. 7. Has breast implant(s). 8. Has reconstructed breast(s). 9. The subject underwent a prior radiotherapy treatment. 10. The subject is undergoing radiotherapy in the thorax area or chemotherapy. 11. The subject is in such a bad health that she is not able to undergo study examinations. 12. Proved or supposed pregnancy. |
1. Soggetti per cui sia nota la possibilità di avere eventi avversi causati da mezzi di contrasto iodati. 2. Soggetti asintomatici e che non mostrino immagini sospette agli esami diagnostici standard. 3. Soggetti la cui ultima mammografia abbia evidenziato un BI-RADS densitale classificato come 1 o 2. 4. Soggetti precedentemente inclusi in questo studio. 5. Soggetti con un seno di dimensioni troppo abbondanti, tali da non permettere un adeguato posizionamento sul ricevitore digitale senza che parte della mammella non venga esclusa dall’immagine. 6. Soggetti che stiano partecipando o abbiano partecipato (nei trenta giorni precedenti l’esame) in altri trial clinici che prevedano la somministrazione di farmaci. 7. Presenza di protesi mammarie 8. Seno/i ricostruito/i 9. Soggetti sottoposti in precedenza a radioterapia. 10. Soggetti in corso di trattamento radioterapico nella zona toracica o in trattamento con chemioterapia. 11. Soggetti in condizioni di salute tanto cagionevoli da non consentire loro di essere sottoposti agli esami previsti dallo studio. 12. Soggetti in stato di gravidanza certo o supposto. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Per case lesion detection sensitivity and specificity from BIRADS for FFDM+US, CESM and MRI pooled across readers scores (threshold for true positive readings = BIRADS 4 - 5) [5] • Performance will be measured using ROC curves. |
Valutazione di sensibilità e specificità delle metodiche CESM, FFDM+US, e RM per caso. I valori verranno raggruppati secondo i BI-RADS diagnostici attribuiti da chi effettuerà le letture (la soglia per definire i veri positivi sarà il BI-RADS 4-5). • La performance verrà misurata valutando le curve ROC. |
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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) |
• Lesion detection sensitivity and specificity from BIRADS scores per reader. • Inter-reader variability on sensitivity and specificity |
• Valutazione della sensibilità delle metodiche definita secondo le classificazioni BI-RADS per esaminatore. • Valutazione della variabilità tra gli esaminatori in termini di sensibilità e specificità. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 33 |
E.8.9.1 | In the Member State concerned days | 0 |