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    Summary
    EudraCT Number:2016-001296-67
    Sponsor's Protocol Code Number:CBFU
    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:2021-06-08
    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 number2016-001296-67
    A.3Full title of the trial
    DUAL ENERGY CONTRAST ENHANCED DIGITAL MAMMOGRAPHY PERFORMANCE EVALUATION IN COMPARISON OF CONVENTIONAL DIGITAL MAMMOGRAPHY, TOMOSINTESIS AND MR IMAGING IN WOMEN FOLLOW-UP FOR BREAST CARCINOMA

    VALUTAZIONE DELLA PERFORMANCE DELLA MAMMOGRAFIA DIGITALE CON MEZZO DI CONTRASTO COMPARATA ALLA MAMMOGRAFIA DIGITALE CONVENZIONALE, ALLA TOMOSINTESI E ALL¿IMAGING DI RISONANZA MAGNETICA NEL FOLLOW-UP DELLE DONNE CON CARCINAMA MAMMARIO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ASSESSMENT OF CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
    VALUTAZIONE DELLA ACCURATEZZA DELLA MAMMOGRAFIA DIGITALE CON MEZZO DI CONTRASTO
    A.3.2Name or abbreviated title of the trial where available
    Cedm Breast Follow-up
    Cedm Breast Follow-up
    A.4.1Sponsor's protocol code numberCBFU
    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 NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    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 supportRicerca Corrente - MinSal
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    B.5.2Functional name of contact pointSC Radiodiagnostica -degenze
    B.5.3 Address:
    B.5.3.1Street AddressVia Mariano Semmola
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0815903738
    B.5.5Fax number0815903825
    B.5.6E-maila.petrillo@istitutotumori.na.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 - 320 MG I/ML SOLUZIONE INIETTABILE FLACONE DA 100 ML
    D.2.1.1.2Name of the Marketing Authorisation holderGE HEALTHCARE S.R.L.
    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.3.1Product nameVisipaque
    D.3.2Product code Iodixanolo
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 Yes
    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 No
    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
    WOMAN WITH BREAST CANCER
    DONNE CON CARCINAMA MAMMARIO
    E.1.1.1Medical condition in easily understood language
    WOMAN WITH BREAST CANCER
    DONNE CON CARCINAMA MAMMARIO
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10006206
    E.1.2Term Breast carcinoma NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    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

    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    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”)

    E.5.1.1Timepoint(s) of evaluation of this end point
    every 12 months
    ogni 12 mesi
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 12 months; every 12 months
    ogni 12 mesi; ogni 12 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 Yes
    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 Yes
    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 trial2
    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.8.5.1Number of sites anticipated in the EEA1
    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 years3
    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 years3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    best practice
    normale pratica clinica
    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 Decision2016-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-18
    P. End of Trial
    P.End of Trial StatusOngoing
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