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    Summary
    EudraCT Number:2012-001582-33
    Sponsor's Protocol Code Number:Er-01-Perf-Stroke
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-001582-33
    A.3Full title of the trial
    Intraindividual cross-over comparison of Gadobutrol and Gadoterate enhanced combined DSC-MR-Perfusion and MR-Angiography in patients with cerebrovascular disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two Gadolinium containing MR contrast media in patients with symptoms of cerebrovascular disease
    A.3.2Name or abbreviated title of the trial where available
    Erlangen Perfusion Stroke
    A.4.1Sponsor's protocol code numberEr-01-Perf-Stroke
    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 SponsorUniversity Hospital Erlangen
    B.1.3.4CountryGermany
    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 supportUniversity of Erlangen; Bayer Healthcare
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Erlangen
    B.5.2Functional name of contact pointProf. Dr. Arnd Dörfler
    B.5.3 Address:
    B.5.3.1Street AddressSchwabachanlage 6
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number49091318539388
    B.5.5Fax number49091318536179
    B.5.6E-mailneuroradiologie@uk-erlangen.de
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous bolus use (Noncurrent)
    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.3.9.3Other descriptive nameGADOBUTROL
    D.3.9.4EV Substance CodeSUB07861MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Dotarem
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravascular use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEGLUMINE GADOTERATE
    D.3.9.3Other descriptive nameDOTAREM
    D.3.9.4EV Substance CodeSUB03121MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 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
    Patients with high grade carotid artery stenosis or acute cerebral ischemia
    E.1.1.1Medical condition in easily understood language
    Patients with Stroke or Stenosis of main brain supplying arteries
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To prove that Gadobutrol provides superior characteristics as compared to Gadoterate in DSC-MR perfusion imaging and contrast-enhanced MR angiography in acute stroke patients and/or patients harboring an intracranial stenosis or extracranial ICA stenosis, assessed by two independent blinded readers.
    E.2.2Secondary objectives of the trial
    • To assess the feasibility of a dual injection protocol in MRI in patients with acute stroke or cerebrovascular diseases.

    • To evaluate descriptively whether Gadobutrol enhanced study protocol provides superior information to guide and tailor further diagnostic and / or therapeutic decisions in this kind of patient population.

    • To evaluate descriptively whether Gadobutrol has a superior vessel contrast and contrast-to-noise ratio in CE-MRA studies (quantitative analysis).

    • To evaluate descriptively whether the vessel conspicuity and stenosis characterization with the use of Gadobutrol is superior (qualitative analysis)

    • To evaluate whether the signal drop after gadobutrol injection in DSC-MRP is superior based on a quantitative analysis of the signal intensity time curve

    • To assess the correlation between the cardiac ejection fraction (if available) and the DSC-MRP quality.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. adult patients, age 18-85 years
    2. with clinically suspected or definite ischemic stroke or an intracranial stenosis (> 50% degree) or extracranial stenosis of the internal carotid artery (> 70%)
    3. clinically indicated initial and follow-up MR examinations of the brain with contrast injection
    4. willing to undergo and comply with all study procedures
    5. written informed consent
    E.4Principal exclusion criteria
    1. who are in pregnancy or nursery. In women with child bearing potential a pregnancy test must be performed directly before each MR examination in order to safely exclude pregnancy. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.
    2. with impaired renal function of CKD stadium 3 and higher (i.e. creatinine clearance < 60 ml/min/1.73m² (Cockroft-Gault formula) or patients on hemodialysis. In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault formula. Calculation of the clearance must be done before begin of study. Serum creatinine value must not be older than one week (7 days) before study related contrast injection.
    3. with renal or liver transplant, including patients with scheduled liver transplant 4. with known allergy or any contraindication to Gadobutrol or Gadoterate.
    5. presenting with a history of anaphylactoid or anaphylactic reaction to any drug or contrast agent.
    6. with high grade cardiac arrhythmia
    7. not being able to remain lying down for at least 30-45 min (e.g., patients with unstable angina, dyspnoea at rest, severe pain at rest, severe back pain)
    8. having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
    9. with a contraindication for MRI (pacemaker, magnetic clips, severe claustrophobia etc.)
    10. being clinically unstable or requiring emergency treatment
    11. with close affiliation with the investigational site; e.g. a close relative of the investigator
    12. who have received any investigational drug within 7 days prior to entering this study
    13. who have received any contrast agent within 24 hours prior to entering this study
    14. who have previously entered this study
    15. participating in another clinical trial
    16. having an underlying disease or concomitant medication which may interfere with efficacy evaluation.
    E.5 End points
    E.5.1Primary end point(s)
    All images will be evaluated for technical adequacy by on site and off site readers to check their eligibility. A blinded read will be performed off site using appropriate technology and equipment. The preparation of the reading will be adhering to international quality standards and documented accordingly. On site, the MR perfusion source data will be analyzed in a standardized way using the Siemens "MRPerf" software. This software generates color-coded parameter maps of mean transit time (MTT), time to peak (TTP), relative cerebral blood volume (rCBV) and relative cerebral blood flow (rCBF). Furthermore, a global bolus plot (GBP) is calculated, showing the time course of the global T2* signal. CE-MRA will be reconstructed on site as rotating thick slice maximum intensity projections (MIP). The blinded readers will have access to the source data, as well as the MIPs. For both CE-MRA and DSC-MRP, the visual (qualitative) image analysis in the blinded read will comprise a dedicated simultaneous matched-pairs assessment from both examinations together. The blinded readers will assess the technical adequacy of the each examination. Images will be rated as
    - 1 = excellent,
    - 2 = adequate (with artefacts but tolerable for assessment)
    - 3 = inadequate (not tolerable for further evaluation).
    As primary efficacy endpoint, an overall assessment of image quality (visual conspicuity and delineation of supraaortic vessels) will be performed by the blinded readers for both CE-MRA and DSC-MRP images combined, respectively:
    “MR study 1 better than MR study 2”
    “both MR studies equal”
    “MR study 2 better than MR study 1”
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints assessed in a blinded read analysis after completion of the study
    E.5.2Secondary end point(s)
    CE-MRA Signal-to-noise ratio will be measured for 23 supraaortic vessel segments:
    • - Aortic arch
    • - Brachiocephalic artery - Right subclavian - Right common carotid artery - Right external carotid artery - Right internal carotid artery
    o o Extracranial segment o Petrous segment o Lacerum segment o Cavernous segment
    - Right vertebral artery
    o o Preforaminal segment o Foraminal segment o C1 loop
    • - Vertebral artery - Left common carotid artery - Left external carotid artery - Left internal carotid artery
    o o Extracranial segment o Petrous segment o Lacerum segment o Cavernous segment
    • - Left subclavian - Left vertebral artery
    o o Preforaminal segment o Foraminal segment o C1 loop
    DSC-MRP As quantitative DSC-MRP parameters highly depend on the current circulation status of the patient, no quantitative assessment will be performed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In a blinded read after the inclusion of all subjects
    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) 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 No
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial1
    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.8.5The 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 Yes
    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
    Blinded Read performed by a CRO - Data analysis planned by an independent CRO
    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
    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: 90
    F.1.3Elderly (>=65 years) No
    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 2012-07-03. 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 state90
    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)
    Post-study therapy will follow routine clinical care.
    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 Decision2012-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
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