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    Summary
    EudraCT Number:2019-000326-22
    Sponsor's Protocol Code Number:IEO960
    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:2020-10-21
    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 number2019-000326-22
    A.3Full title of the trial
    The role of Contrast-Enhanced Spectral Mammography (CESM) in the diagnostic process of breast cancer: can it improve specificity of first-line examinations and therefore reduce the suspicious lesions that undergo vacuum assisted breast biopsy (VABB)?
    Il ruolo della mammografia con mezzo di contrasto [Contrast-Enhanced Spectral Mammography (CESM)] nella diagnostica del tumore alla mammella: si può incrementare la specificità delle indagini diagnostiche di prima linea e ridurre il numero di biopsie mammarie con tecnica VABB?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the use of contrast agent in mammography to improve the specificity of breast cancer diagnosis
    Valutazione dell’utilizzo del mezzo di contrasto nella mammografia per incrementare la specificità delle indagini diagnostiche per il tumore mammario.
    A.3.2Name or abbreviated title of the trial where available
    IEO 960
    IEO 960
    A.4.1Sponsor's protocol code numberIEO960
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo di Oncologia
    B.5.2Functional name of contact pointUfficio Studi Clinici e Attività Re
    B.5.3 Address:
    B.5.3.1Street Addressvia Ripamonti 435
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number0257489848
    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 ULTRAVIST - 370 MG/ML SOLUZIONE INIETTABILE 1 FLACONE 100 ML
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameULTRAVIST 370 mg/ml
    D.3.2Product code [ULTRAVIST 370 mg/ml]
    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 INNIOPROMIDE
    D.3.9.1CAS number 73334-07-3
    D.3.9.2Current sponsor codeiopromide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    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
    Patients with breast lesions undergoing further examination
    Pazienti in accertamento per lesioni mammarie
    E.1.1.1Medical condition in easily understood language
    Diagnostic workup for breast lesions
    Esame di approfondimento per lesioni mammarie
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061021
    E.1.2Term Breast disorder
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the role of Contrast-Enhanced Spectral Mammography in the diagnostic workup of breast cancer
    Approfondire il ruolo della mammografia con mezzo di contrasto nella diagnostica del tumore della mammella
    E.2.2Secondary objectives of the trial
    To evaluate CESM diagnostic performance in suspicious breast lesions
    Analizzare il risultato diagnostico del CESM nella valutazione delle lesioni mammarie sospette
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Woman with suspicious breast lesions from FFDM, US and/or MR imaging and for whom a presurgical evaluation is recommended
    • The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations
    • Donne con sospette lesione mammarie identificate mediante mammografia, ecografia e/o risonanza magnetica e per le quali è necessaria una valutazione pre – chirugica
    • La paziente deve essere in buona salute per poter affrontare le valutazioni standard e la CESM
    E.4Principal exclusion criteria
    • The subject is known to have risks of adverse effects with iodine contrast agents.
    • The subject is asymptomatic and without suspicious findings from routine imaging.
    • The subject is participating or has participated (within the prior 30 days) in another clinical
    • La paziente presenta rischi di eventi avversi con mezzi di contrasto contenenti iodio.
    • La paziente è asintomatico e non presenta immagini sospette nell’ analisi di routine.
    • La paziente partecipa o ha partecipato (entro i 30 giorni precedenti) ad un'altra sperimentazione clinica
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery)
    Valutare il Valore Predittivo Negative (VPN) del CESM versus il VPN dell’istologia della biopsia o dell’istologia dopo la chirurgia
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months in surgery, 2-3 years in case of follow up
    2 mesi in caso di intervento, 2-3 anni in caso di follow up
    E.5.2Secondary end point(s)
    To establish CESM diagnostic performance in suspicious breast lesions using histology from VABB as gold standard correlating the definite result (after surgery) with preoperative imaging (accuracy).
    Analizzare il risultato diagnostico del CESM nella valutazione delle lesioni mammarie sospette usando l'istologia mediante VABB come standard di riferimento, correlando il risultato definito (dopo l'intervento chirurgico) con l'imaging preoperatorio (accuratezza).
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months in surgery, 2-3 years in case of follow up
    2 mesi in caso di intervento, 2-3 anni in caso di follow up
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    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)
    According to biopsy histological results patients are candidate to follow up or surgery
    A seconda del risultato dell'istologia della biopsia le pazienti sono candidate al follow up o chirurgia
    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 Decision2020-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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