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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-009598-90
    Sponsor's Protocol Code Number:91782
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-19
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-009598-90
    A.3Full title of the trial
    Estudio abierto, multicéntrico, en fase III, con lectura ciega de imágenes, para evaluar la eficacia y la seguridad de una única inyección intravenosa de 0,1 mmol / kg de peso corporal de gadobutrol 1,0 molar (Gadovist®) en pacientes con diagnóstico reciente de cáncer de mama referidos para resonancia magnética de mama, realzada con contraste


    An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and safety of gadobutrol 1.0 molar (Gadovist®) for breast MRI
    A.4.1Sponsor's protocol code number91782
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer Health Care AG (study performed by Bayer Schering Pharma AG)
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisation
    B.5.2Functional name of contact point
    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 Gadovist® 1.0 mmol/ml, solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GMBH
    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 nameGadovist® 1.0 mmol/ml, solución inyectable
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNgadobutrol
    D.3.9.1CAS number 138071-82-6
    D.3.9.2Current sponsor codeBay86-4875
    D.3.9.3Other descriptive nameGADOBUTROL
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 typemedio de contraste
    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
    Pacientes con cáncer de mama histologicamente confirmado referidos a MRM antes de la cirugia y despues de la XRM
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012992
    E.1.2Term Digital mammography
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. La superioridad de la MRM combinada sin realzar y realzada con gadobutrol frente a la MRM sin realzar.
    2. La superioridad de la MRM combinada sin realzar y realzada con gadobutrol más MRX frente a la MRM sin realzar más MRX.
    Sobre la base de la precisión categórica a la hora de determinar la extensión del tumor en la región mamaria en función de tres categorías (presencia de una patología maligna unifocal, multifocal o no maligna) y comprobada mediante el patrón diagnóstico de referencia predefinido (histopatología o, como alternativa, MRX más ecografía).
    E.2.2Secondary objectives of the trial
    1. La MRM combinada sin realzar y realzada con gadobutrol frente a la MRM sin realzar.
    2. La MRM combinada sin realzar y realzada con gadobutrol más MRX frente a la MRM sin realzar más MRX.
    3. La MRM combinada sin realzar y realzada con gadobutrol más MRX frente a la MRX sola.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Tener como mínimo 18 años.
    2. Tener un diagnóstico de cáncer de mama probado histológicamente tras haberse sometido a una MRX de ambas mamas (de acuerdo con el American College of Radiology [ACR] en un plazo máximo de 6 semanas antes de inscribirse en el estudio) y haber sido referido para realizarse una MRM realzada con contraste antes de someterse a cirugía de mama.
    3.Si es mujer, se necesita una MRX digital en cualquiera de estos casos:
    a. La paciente tiene menos de 50 años
    b. Las mamas de la paciente presentan densidad heterogénea o densidad extrema (en base a los criterios cuantitativos para las categorías de densidad mamográfica que establece BI-RADS, se considera que la densidad es heterogénea si hay una variación del 51%- 75% y que la densidad es extrema si es > 75%).
    c. No se encuentra en el período de postmenopausia (se entiende la postmenopausia como 12 meses como mínimo sin menstruación antes de la inclusión).
    4. Desea someterse a exámenes de MRM realzada con contraste con gadobutrol.
    5. Desea y puede someterse a todos los procedimientos del estudio especificados en el protocolo.
    6. Si es mujer, o bien no está en edad fértil, o bien está en edad fértil pero está utilizando métodos anticonceptivos aceptados médicamente y se ha sometido a una prueba de embarazo en orina y ha dado negativo en el plazo de 1 hora antes de la administración de gadobutrol.
    7. Si es una mujer en edad fértil, la MRM debería realizarse entre el 7º y el 14º día del ciclo menstrual.
    8. Tiene una velocidad de filtración glomerular estimada (eGFR) &#8805; 60 ml/min/1,73 m2 derivada del resultado de la creatinina de suero en un plazo de 2 semanas antes de su inscripción en el estudio.
    9. Está bien informado del estudio, incluidas las disposiciones de la Ley HIPAA de EE.UU. (Health Insurance Portability and Accountability Act), si procede, y ha dado su consentimiento para participar en el estudio por escrito.
    E.4Principal exclusion criteria
    1. La paciente es una mujer embarazada o en período de lactancia.
    2. Se le ha administrado un producto en investigación o ha participado en cualquier otro ensayo clínico en un plazo de 30 días antes de inscribirse en este estudio.
    3. Haya participado anteriormente en este estudio.
    4. Tiene alguna contraindicación para el examen con MRM (p. ej., implantes de metal, fobia) o para medios de contraste con gadolinio.
    5. Tiene antecedentes de reacciones alérgicas severas o anafilactoides a cualquier alérgeno, incluidos los fármacos o los medios de contraste.
    6. Se le ha administrado cualquier medio de contraste en un plazo de 24 horas antes de la MRM del estudio o tiene programado que se le administre en un plazo de 24 horas después de la MRM del estudio.
    7. Se considera clínicamente inestable o su curso clínico durante el período de estudio es impredecible (p. ej., a causa de una cirugía previa o de insuficiencia renal aguda).
    8. Padece una enfermedad cardiovascular importante (p. ej., síndrome de QT prolongado, infarto agudo de miocardio [< 14 días], angina inestable, insuficiencia cardiaca congestiva de clase IV de la escala de la New York Heart Association) o ictus agudo (< 48 horas).
    9. Tiene una insuficiencia renal aguda de cualquier gravedad a causa de un síndrome hepatorrenal o en el período de transplante de hígado perioperatorio, o padece una insuficiencia renal aguda o crónica moderada o severa (velocidad de filtración glomerular < 60 ml/min/1,73 m2).
    10. Ha recibido quimioterapia o terapia hormonal para cáncer de mama en los últimos 6 meses.
    11. Se ha sometido a una terapia de sustitución hormonal en un plazo de 4 semanas antes de la administración del fármaco del estudio.
    12. Se le ha programado o es probable que necesite una cirugía o una biopsia en un plazo de 24 horas a partir de la aplicación del fármaco del estudio.
    13. Ha sido sometido a una biopsia excisional o a una cirugía de mama menos de 6 meses antes de su inscripción y entre la MRX y la MRM del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Las variables primarias de eficacia son la determinación de la extensión de la patología maligna evaluada en cada región mamaria (unifocal o multifocal enfermedad maligna , o no presencia de enfermedad maligna) para la MRM sin realzar frente a la MRM combinada sin realzar y realzada con gadobutrol, y para la MRM combinada sin realzar y realzada con gadobutrol más MRX frente a la MRM sin realzar más MRX tal como se determina en la evaluación de los lectores en condiciones de enmascaramiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Para los pacientes a los que no se les programe una exploración ecográfica, el estudio finalizará con el seguimiento a las 24 horas.
    Para los pacientes a los que se les programe una exploración ecográfica, el estudio finalizará con la exploración ecográfica.
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 2010-02-19. 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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 440
    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)
    No aplica en este ensayo
    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 Decision2010-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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