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    Summary
    EudraCT Number:2012-002784-10
    Sponsor's Protocol Code Number:CESM
    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:2012-06-26
    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 number2012-002784-10
    A.3Full title of the trial
    Clinical trial comparing contrast enhanced spectral digital mammography (CESM) and magnetic resonance imaging (MRI) to evaluate the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer.
    Trial clinico di comparazione della mammografia digitale con mezzo di contrasto (CESM) alla risonanza magnetica (RM) nella stima dell'efficacia del trattamento di chemioterapia neoadiuvante in pazienti con neoplasia mammaria localmente avanzata.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial comparing contrast enhanced spectral digital mammography (CESM) and magnetic resonance imaging (MRI) to evaluate the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer.
    Comparazione della mammografia digitale con mezzo di contrasto rispetto alla Risonanza Magnetica in pazienti in trattamento con chemioterapia neoadiuvante per carcinoma della mammella
    A.4.1Sponsor's protocol code numberCESM
    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 SponsorAZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
    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 supportAzienda Ospedaliera S. Maria Nuova
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda ospedaliera S. Maria Nuova
    B.5.2Functional name of contact pointS.C. di Radiologia
    B.5.3 Address:
    B.5.3.1Street AddressViale Risorgimento, 80
    B.5.3.2Town/ cityReggio Emilia
    B.5.3.3Post code42123
    B.5.3.4CountryItaly
    B.5.4Telephone number+390522296369
    B.5.6E-mailpattacini.pierpaolo@asmn.re.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 OPTIRAY*EV 10SIR 100ML 300MG/M
    D.2.1.1.2Name of the Marketing Authorisation holderCOVIDIEN ITALIA SpA
    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 Concentrate for solution for injection/infusion
    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 INNioversol
    D.3.9.1CAS number 87771-40-2
    D.3.9.4EV Substance CodeSUB08262MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number37500
    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
    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
    patient with cito-istologic diagnosis of locally advanced breast cancer
    Diagnosi accertata cito-istologicamente di carcinoma della mammella localmente avanzato
    E.1.1.1Medical condition in easily understood language
    patient with breast cancer
    Pazienti con cancro della mammella
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to compare CE-MRI and CESM in the evaluation of neoadjuvant treatment in patients with locally advanced breast cancer, histopathological evaluation being the gold standard
    valutare l’efficacia del trattamento neoadiuvante in pazienti con diagnosi di neoplasia mammaria localmente avanzata confrontando la CESM con la risonanza magnetica con mezzo di contrasto, mantenendo come gold standard di riferimento i parametri apprezzabili nel tessuto mammario escisso chirurgicamente
    E.2.2Secondary objectives of the trial
    To evaluate the diagnostic performance of both techniques and their agreement will be assessed. An evaluation of the impact of CESM on surgical planning will also be performed
    Analizzare la concordanza tra il metodo attualmente in uso e quello sperimentale, quantificando prima la performance diagnostica delle singole metodiche. Verrà valutato anche se e come la nuova metodica CESM in studio modificherà l’approccio chirurgico ed il tipo d’intervento operatorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. a diagnosis of breast cancer that will undergo neoadjuvant chemotherapy;
    b. Over 18 years of age;
    c. Agreement to undergo the study procedures and to sign the informed consent.
    a. pazienti con diagnosi cito-istologica di carcinoma mammario da sottoporre a chemioterapia neoadiuvante;
    b. pazienti di età maggiore di anni 18.
    c. pazienti in grado e disposte a rispettare le procedure di studio e che hanno firmato e datato il modulo di consenso informato.
    E.4Principal exclusion criteria
    a. those with a known mutation of the gene BRCA;
    b. those who cannot undergo MR examinations or for whom it is contraindicated;
    c. those who are pregnant, demonstrated by blood tests;
    d. those who have contraindications to the administration of iodine or gadolinium contrast agent (high creatinine value, renal insufficiency) or allergies to the contrast agent. Blood tests including creatinine levels will be performed every three weeks by the Oncology Department.
    a. pazienti con accertata mutazione del gene BRCA;
    b. pazienti che presentano controindicazioni all’esame di risonanza magnetica alla mammella o che non sono in grado di effettuare l’esame;
    c. pazienti in stato di gravidanza accertata tramite dosaggio ormonale o sospetta;
    d. pazienti con controindicazioni alla somministrazione di mezzo di contrasto iodato o al gadolinio (elevati valori di creatinina, insufficienza renale, …) o con pregresse allergie alla somministrazione di mezzo di contrasto. Le analisi emato-chimiche comprendenti il dosaggio ematico della creatininemia vengono effettuate dal Servizio di Oncologia ogni 3 settimane.
    E.5 End points
    E.5.1Primary end point(s)
    The parameters that will be evaluated are:
    - lesion size, defined as the major axis of the lesion according to RECIST criteria (Response Evaluation Criteria in Solid Tumours), compared with the histologic evaluation on the surgical sample as a gold standard;
    - lesion location in one of the four quadrants (compared with surgical findings);
    - lesion shape (Fischer’s score as discussed in Girardi W. et al., Radiol. Med. 2010: round, oval, polygonal, linear, dendritic, spiculated);
    - vascularization (contrast agent uptake; qualitative evaluation of contrast agent uptake [strong, intermediate, weak], and assessment of the kinetics by means of an intensity-time curve; contrast agent uptake pattern: homogeneous, unhomogeneous, septate, rim);
    - multifocality;
    - borders (according to Fischer’s score: well or bad defined)
    In particolare il confronto tra le due metodiche verrà eseguito mediante una griglia di parametri diagnostici, raccolti in due distinte tabelle per ogni paziente, volti a paragonare l’accuratezza diagnostica della CESM e della RM di ogni singolo parametro in studio e successivamente verrà valutata la concordanza tra le due tecniche di studio.
    Tali parametri nello specifico saranno:
    - dimensione della lesione valutandone l’asse maggiore secondo i criteri RECIST: Response Evaluation Criteria in Solid Tumors (confronto con istologico chirurgico che verrà considerato come gold standard);
    - posizione della lesione nei quattro quadranti della mammella (confronto con posizione chirurgica);
    - forma della lesione (score di Fischer (Girardi W. et al., Radiol. Med. 2010): rotonda, ovale, poligonale, lineare, dendritica e spiculata);
    - vascolarizzazione (assenza o presenza di contrasto; valutazione qualitativa soggettiva dell’intensità di contrasto [forte, intermedio e debole] ed eventuale valutazione del pattern dinamico mediante curva d’intensità-tempo; pattern d’impregnazione contrastografica: omogeneo, disomogeneo, settato e ad anello);
    - multicentricità-multifocalità;
    - margini (score di Fischer: ben definiti o mal definiti);
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    - morphologic and dynamic correlation with histotype;
    - correlation with ultrasounds and mammography.
    - correlazione morfo-dinamica con l’istotipo e con le caratteristiche molecolari (confronto con caratterizzazione istologica e reperto istologico chirurgico che verrà considerato il gold standard);
    - correlazione con il reperto eco-mammografico 2D.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 Yes
    E.6.13.1Other scope of the trial description
    comparison between two diagnostic techniques
    confronto tra metodiche diagnostiche
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 months24
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-06-26. Yes
    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 state50
    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)
    Clinical practice assistance
    Assistenza secondo 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 Decision2012-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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