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    Clinical Trial Results:
    Intraindividual cross-over comparison of Gadobutrol and Gadoterate enhanced combined DSC-MR-Perfusion and MR-Angiography in patients with cerebrovascular disease

    Summary
    EudraCT number
    		 2012-001582-33
    Trial protocol
    		 DE  
    Global end of trial date
    01 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2020
    First version publication date
    10 May 2020
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    Er-01-Perf-Stroke
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Schwabachanlage 6, Erlangen, Germany, 91054
    Public contact
    Prof. Dr. Arnd Dörfler, University Hospital Erlangen, 49 091318539388, neuroradiologie@uk-erlangen.de
    Scientific contact
    Prof. Dr. Arnd Dörfler, University Hospital Erlangen, 49 091318539388, neuroradiologie@uk-erlangen.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    There are no measures necessary for the examination. For minimise distress they get earphones for sound noising. If patients are scared or had claustrophobic the can get sedatives. We monitor patients with video and they all have a button for emergency cases
    Background therapy
    		 no background therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 73
    Worldwide total number of subjects
    73
    EEA total number of subjects
    73
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    35
    From 65 to 84 years
    37
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 We recruited 73 Patients into the trial from november 2012 until january 2016

    Pre-assignment
    Screening details
    		 Inclusion of Subjects from 18-85 years with with clinically suspected or definite ischemic stroke or an intracranial stenosis (> 50% degree) or extracranial stenosis of the internal carotid artery (> 70%). Also clinically indicated initial and follow-up MR examinations of the brain with contrast injection. Written inform consent

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    The blinded readers will have access to the source data and 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. The blinded readers will assess the technical adequacy of each examination.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ARM 1
    Arm description
    		 Patients receive 2 MRI brain examinations to assess cerebrovascular disease 1. MRI with contrast agent Gadovist® (Gadobutrol, 1.0 M gadolinium chelate, Bayer Healthcare) 2. MRI with contrast agent Dotarem® (Gadoterate, 0.5 M gadolinium chelate, Guerbet
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadovist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gadobutrol, 1.0 M gadolinium chelate, Bayer Healthcare

    Investigational medicinal product name
    Dotarem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gadoterate, 0.5 M gadolinium chelate, Guerbet GmbH

    Arm title
    		 ARM 2
    Arm description
    		 Patients receive 2 MRI brain examinations 1. MRI with contrast agent Dotarem® (Gadoterate, 0.5 M gadolinium chelate, Guerbet GmbH); 2. MRI with contrast agent Gadovist® (Gadobutrol, 1.0 M gadolinium chelate, Bayer Healthcare)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadovist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gadobutrol, 1.0 M gadolinium chelate, Bayer Healthcare

    Investigational medicinal product name
    Dotarem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gadoterate, 0.5 M gadolinium chelate, Guerbet GmbH

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: only a blinded read by assessor was done
    Number of subjects in period 1
    		ARM 1 ARM 2
    Started
    34
    36
    Completed
    28
    29
    Not completed
    6
    7
         Physician decision
    6
    7

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: there are at least 54 patients included. We indicated 57 but 3 hat to many major motion artefact
    Reporting group values
    		 overall trial Total
    Number of subjects
    		 57 57
    Age categorical
    1 patient were included at the group of 85 years or older 27patients were included at the group of 65-84 years 29 patients were included at the group of 18-64 years The mean Age is 64 years
    Units: Subjects
        Adults (18-64 years)
    		 29 29
        From 65-84 years
    		 27 27
        85 years and over
    		 1 1
    Age continuous
    73 Patients analysed with a mean age of 64 and a median age of 65 The youngest patient was 26 years and the oldest was 85 years at inclusion
    Units: years
        median (full range (min-max))
    		 65 (26 to 85) -
    Gender categorical
    60% (36) male and 40% (21) female patients included
    Units: Subjects
        Female
    		 36 36
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    ARM 1
    Reporting group description
    		 Patients receive 2 MRI brain examinations to assess cerebrovascular disease 1. MRI with contrast agent Gadovist® (Gadobutrol, 1.0 M gadolinium chelate, Bayer Healthcare) 2. MRI with contrast agent Dotarem® (Gadoterate, 0.5 M gadolinium chelate, Guerbet

    Reporting group title
    ARM 2
    Reporting group description
    		 Patients receive 2 MRI brain examinations 1. MRI with contrast agent Dotarem® (Gadoterate, 0.5 M gadolinium chelate, Guerbet GmbH); 2. MRI with contrast agent Gadovist® (Gadobutrol, 1.0 M gadolinium chelate, Bayer Healthcare)

    Primary: Image quality

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    End point title
    		 Image quality
    End point description
    As primary efficacy endpoint, an overall assessment of image quality will be performed by the blinded readers for both CE-MRA and DSC-MRP images combined: MR study 1 better than MR study 2 Both MR studies equal MR study 2 better than MR study 1
    End point type
    Primary
    End point timeframe
    no timeframe applicable
    End point values
    		 ARM 1 ARM 2
    Number of subjects analysed
    28 [1]
    26 [2]
    Units: arbitary unit
        MR study 1 better than MR study 2
    10
    12
        Both MR studies equal
    12
    11
        MR study 2 better than MR study 1
    6
    3
    Notes
    [1] - finally 28 patients performed visit 2 from 34 patients who started at this ARM
    [2] - finally 29 patients startet visit 2 from 36. 3 patients who started Visit 2 get no 2nd infjection
    Statistical analysis title
    		 Primary Efficacy
    Comparison groups
    ARM 1 v ARM 2
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events where reported earliest after written inform consent and latest 30 minutes after last examination
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Headache
    Reporting group description
    		 The event was headache. It was considered not to be related to study drug

    Serious adverse events
    		 Headache
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Headache
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Nervous system disorders
    Headache
    Additional description: Patient get headache after Dotarem injection
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In this study there was a drop out rate of 22% as 16 patients of 73 screened patients did not complete the 2nd MRI.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28913611
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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