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    Summary
    EudraCT Number:2011-002288-29
    Sponsor's Protocol Code Number:IEOS626/311
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002288-29
    A.3Full title of the trial
    New frontiers in breast imaging: contrast enhanced digital mammography. - Clinical performance of contrast-enhanced spectral mammography (CESM - SenoBright) in pre-surgical evaluation of extent of malignancy in a population of women with breast cancer.
    Le nuove frontiere dell'imaging senologico: la mammografia digitale, con mezzo di contrasto. Studio sull'efficacia clinica della mammografia a raggi X eseguita con mezzo di contrasto (CESM - SenoBright') nella valutazione pre-chirurgica dell'estensione di malattia in una popolazione di donne affette da neoplasia mammaria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study about clinical efficacy of mammography performed injecting a contrast medium in women with breast cancer.
    Studio sull’efficacia clinica della mammografia effettuata iniettando un mezzo di contrasto in donne con tumore al seno.
    A.4.1Sponsor's protocol code numberIEOS626/311
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorISTITUTO EUROPEO DI ONCOLOGIA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIstituto Europeo Oncologia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo Oncologia
    B.5.2Functional name of contact pointUfficio studi clinici
    B.5.3 Address:
    B.5.3.1Street Addressvia Ramusio 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number02 57 48 98 48
    B.5.5Fax number02 57 48 97 81
    B.5.6E-mailufficio.studiclinici@ieo.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VISIPAQUE*320MG I/ML FLPP 50ML
    D.2.1.1.2Name of the Marketing Authorisation holderGE HEALTHCARE Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIODIXANOL
    D.3.9.1CAS number 92339112
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB08213MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMEZZO DI CONTRASTO IODATO
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Breast cancer
    Tumore mammario
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Tumore mammario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012992
    E.1.2Term Digital mammography
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 mesi
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months
    18 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months33
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state178
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    ROUTINE TREATMENT
    NORMALE PROGRAMMA DI ASSISTENZA
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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