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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   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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    EudraCT Number:2008-000583-16
    Sponsor's Protocol Code Number:312041
    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:2008-10-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2008-000583-16
    A.3Full title of the trial
    Multi-center, randomized comparison study to eVALUatE outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI of the liver in comparison to extracellular contrast media (ECCM)-enhanced MRI and contrast-enhanced computed tomography (CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases

    Estudio multicéntrico, aleatorizado, comparativo para eVALUar los resultados y la nEcesidad de recursos de imágen y tratamiento después de resonancia magnética hepática con contraste PrimovistR (RM-Primovist) en comparación con resonancia magnética con contraste extracelular (RM-CEC) y estudio dinámico con tomografía computerizada con contraste (TC-CC) en pacientes con historia clínica de cáncer colorrectal y metástasis hepáticas metacrónicas conocidas o sospechadas

    A.3.2Name or abbreviated title of the trial where available
    Primovist VALUE study
    A.4.1Sponsor's protocol code number312041
    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 Schering Pharma AG (BSP)
    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.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. name Primovist 0.25 mmol/ml Inyectable, jeringa precargada
    D. 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 namePrimovist 0,25 mmol/ml Injektionslösung, Fertigspritze
    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 INNÁcido gadoxético disódico
    D.3.9.1CAS number 135326-22-6
    D.3.9.2Current sponsor codeZK 139834
    D.3.9.3Other descriptive nameGd-EOB-DTPA
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.025
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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. 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 historia de cáncer colorrectal y conocimiento o sospecha de metástasis hepática metacrónica en los que está indicada una prueba de imagen tomográfica con contraste del hígado (p.e. RM-CEC o TC-CC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar los resultados y la necesidad de recursos de imágen y de tratamiento tras la RM con Primovist (RM-PV) en comparación con RM con CEC (RM-CEC) y TC con contraste (TC-CC) en pacientes con historia de cáncer colorrectal y metástasis hepáticas conocidas o sospechadas, basándose en la evaluación de lo siguiente:
    • Proporción de pacientes de los que se requieren imágenes adicionales para llegar a una decisión terapéutica tras las imágenes del hígado iniciales con RM-PV, RM-CEC o TC-CC (variable de eficacia principal)
    • Proporción de pacientes con modificación intraoperatoria de los planes quirúrgicos basados en RM-PV, RM-CEC o TC-CC
    • Rendimiento del diagnóstico de cualquiera de las RM-PV, RM-CEC o TC-CC en comparación con el diagnóstico definitivo
    • Confianza en el diagnóstico y en la decisión terapéutica
    • Necesidad de recursos de imagen y de tratamiento tras RM-PV, RM-CEC o TC-CC

    E.2.2Secondary objectives of the trial
    Evaluar la seguridad de la RM-PV en comparación con las RM-CEC y TC-CC en pacientes con metástasis hepática conocida o sospechada, basándose en la evaluación de los acontecimientos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes con metástasis hepática metacrónica conocida o sospechada, secundaria a cáncer colorrectal que hayan sido programados para obtención de imágenes tomográficas adicionales con contraste
    2. Pacientes dispuestos a someterse a los procedimientos del estudio
    3. Pacientes que estén completamente informados acerca del estudio y hayan firmado el formulario de consentimiento informado
    E.4Principal exclusion criteria
    1.Pacientes (hombres o mujeres) menores de 18 años
    2.Pacientes que hayan participado anteriormente en este estudio
    3.Pacientes que hayan recibido cualquier material de contraste durante las 24 horas anteriores a la inyección del producto en estudio, o que estén programados para recibir cualquier medio de contraste durante las 24 horas posteriores a la inyección
    4.Pacientes que hayan recibido o que recibirán cualquier otra medicación que esté en estudio durante las 48 horas previas a la inyección de la medicación del estudio o durante la participación en el estudio
    5.Mujeres embarazadas, en periodo de lactancia o en edad fértil y que no tengan una prueba de embarazo en orina negativa en la visita(s) basal
    6.Pacientes no seleccionables para la inyección del medio de contraste (MC) de acuerdo con las indicaciones de la etiqueta del producto
    7.Pacientes programados para RM específica del hígado diferente de RM con Primovist, p.e. RM con Multihance, Teslascan o SPIO
    8.Pacientes que requieran tratamiento de emergencia
    9.Pacientes clínicamente inestables y aquellos con un curso clínico impredecible (p.e. debido a una cirugía anterior, infarto agudo de miocardio)
    10.Pacientes con cualquier estado físico o mental que interfiera a la hora de firmar el consentimiento informado
    11.Pacientes con reacción anafilactoide o anafiláctica conocida a cualquier medio de contraste o hipersensibilidad a cualquier alérgeno, incluyendo medicamentos
    12.Pacientes en los que esté contraindicada la RM o la TC.
    13.Pacientes con disfunción renal (p.e. fallo renal agudo) o pacientes en diálisis.
    14.Afiliación cercana con el centro; p.e., un familiar del investigador, persona dependiente (p.e., empleado o estudiante del centro)
    E.5 End points
    E.5.1Primary end point(s)
    Proporción de pacientes de los que se requieren imágenes adicionales para llegar a una decisión terapéutica tras las imágenes del hígado iniciales con RM-PV, RM-CEC o TC-CC

    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 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 Yes
    E.6.13.1Other scope of the trial description
    Evaluación económica en salud
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 el paciente individual el estudio finaliza al finalizar el período de seguimiento de 1 hora post-inyección (p.i.). En lo relativo al registro de datos, el estudio finaliza con la obtención de datos sobre el diagnóstico definitivo basados en EIO/histopatología o los datos clínicos obtenidos durante los 3 meses posteriores al procedimiento de obtención de imágenes inicial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 2008-10-28. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 660
    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 Decision2008-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-30
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