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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2008-000583-16
    Sponsor's Protocol Code Number:312041
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-14
    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 ConcernedNetherlands - Competent Authority
    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
    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.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 Primovist 0.25 mmol/ml Injektionslösung, Fertigspritze
    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 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 INNGadoxetic acid, disodium
    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.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 typeContrast Medium
    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 history of colorectal cancer and known or suspected metachronous liver metastasis(es) scheduled to undergo contrast-enhanced tomographic imaging (i.e. CE-MRI or CE-CT) of the liver
    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
    The main objective of this study is to evaluate outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI (PV-MRI) as compared to ECCM-enhanced MRI (ECCM-MRI) and contrast-enhanced CT (CE-CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases based on the evaluation of the following:
    • Proportion of patients for whom further imaging is required to come to a therapy
    decision after initial imaging of the liver with either PV-MRI, ECCM-MRI or CE-CT
    (primary efficacy variable)
    • Proportion of patients with intra-operatively modified surgical plans based on
    either PV-MRI, ECCM-MRI or CE-CT
    • Diagnostic performance of either PV-MRI, ECCM-MRI or CE-CT in comparison to
    final diagnosis
    • Confidence in diagnosis and therapeutic decision
    • Resource needs for imaging and treatment after either PV-MRI, ECCM-MRI or CE-CT
    E.2.2Secondary objectives of the trial
    Another objective of this study is to assess safety of PV-MRI as compared to ECCM-MRI and CE-CT in patients with a history of colorectal cancer and known or suspected liver metastases based on the evaluation of adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with known or suspected metachronous liver metastases secondary to
    colorectal cancer who are scheduled for further contrast-enhanced tomographic
    imaging
    2. Patients willing to undergo the study procedures
    3. Patients who are fully informed about the study and have signed the informed
    consent form
    E.4Principal exclusion criteria
    1. Patients (men or women) under 18 years of age
    2. Patients who have previously entered this study
    3. Patients who have received any contrast material within 24 hours before injection
    of study drug, or who are scheduled to receive any contrast material within
    24 hours after injection
    4. Patients who have received or will receive any investigational drug 48 hours
    before injection of the study drug or during study participation.
    5. Women who are pregnant, lactating or who are of childbearing potential and have
    not had a negative urine pregnancy test at baseline visit(s).
    6. Patients not eligible to contrast media (CM) injection according to product labeling
    7. Patients scheduled for liver-specific MRI other than Primovist-enhanced MRI, e.g.
    Multihance-, Teslascan- or SPIO-enhanced MRI
    8. Patients who require emergency treatment
    9. Patients who are clinically unstable and whose clinical course is unpredictable
    (e.g. due to previous surgery, acute myocardial infarction)
    10. Patients with any physical or mental status that interferes with the signing of
    informed consent
    11. Patients with known anaphylactoid or anaphylactic reaction to any contrast
    media or hypersensitivity to any allergen including drugs
    12. Patients with a contraindication for MRI or CT.
    13. Patients with impaired renal function (e.g. acute renal failure) or patients on
    dialysis.
    14. Close affiliation with the investigational site; e.g., a relative of the investigator,
    dependent person (e.g., employee or student of the investigational site)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in each of the three treatment groups for whom further imaging is required after initial imaging to come to a therapy decision
    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
    Health economic evaluation (outcome and recource needs)
    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) 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    For the individual patient the study ends with the end of the follow-up period 1 h post injection (p.i.) after the last imaging. With regard to data recording, the study ends with obtaining the data on final diagnosis based on either IOUS/histopathology or clinical data obtained within 3 month after the initial imaging procedure.
    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 2008-10-14. 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 state150
    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 Decision2008-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-31
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