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    Clinical Trial Results:
    Breast lesion detection and characterization at contrast-Enhanced MRI of the breast: comparison of gadoterate meglumine versus gadobenate dimeglumine at 3 Tesla

    Summary
    EudraCT number
    		 2011-005498-21
    Trial protocol
    		 AT  
    Global end of trial date
    25 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2020
    First version publication date
    30 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bracco
    Sponsor organisation address
    Via Caduti di Marcinelle 13, Milano, Italy, 20134
    Public contact
    Medical University of Vienna, Medical University of Vienna, 0043 4040048200, thomas.helbich@meduniwien.ac.at
    Scientific contact
    Medical University of Vienna, Medical University of Vienna, thomas.helbich@meduniwien.ac.at
    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
    24 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to intraindividually compare the use of gadobenate dimeglumine (MultiHance, Bracco Imaging, Milan, Italy) and gadoterate meglumine (DOTAREM, Guerbet, France) for breast MR imaging by using a prospective study design, evaluated independently by blinded readers.
    Protection of trial subjects
    insurance, patient informed consents
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    100
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 consecutive women presenting for the assessment of abnormal breast imaging findings (ie, classified as BI-RADS 0, 4, or 5) on mammography, tomosynthesis, or ultrasound were eligible for this study. Excluded women below 18 years of age, women who were pregnant or lactating or treatment of breast, contraindication to MRI

    Pre-assignment
    Screening details
    		 Consecutive women presenting for the assessment of abnormal breast imaging findings (ie, classified as BI-RADS 0, 4, or 5) on mammography, tomosynthesis, or ultrasound were eligible for this study. Excluded women below 18 years of age, women who were pregnant or lactating or treatment of breast, contraindication to MRI

    Pre-assignment period milestones
    Number of subjects started
    		 104
    Number of subjects completed
    		 104

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Each reader was blinded to all clinical and radiological information.

    Arms
    Arm title
    		 comparison
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    gadobenate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    0,0075mmol/kg

    Number of subjects in period 1
    		comparison
    Started
    104
    Completed
    104

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 104 104
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 100 100
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 104 104
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    CE-MRI
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis was performed on a per-breast basis; thus, the accuracy of L-CEM vs. CE-MRI to analyze multifocality or multicentricity was not assessed.

    Subject analysis set title
    CEM
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis was performed on a per-breast basis; thus, the accuracy of L-CEM vs. CE-MRI to analyze multifocality or multicentricity was not assessed.

    Subject analysis sets values
    		 CE-MRI CEM
    Number of subjects
    104
    104
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    100
    100
        From 65-84 years
    4
    4
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    104
    104
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    comparison
    Reporting group description
    		 -

    Subject analysis set title
    CE-MRI
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis was performed on a per-breast basis; thus, the accuracy of L-CEM vs. CE-MRI to analyze multifocality or multicentricity was not assessed.

    Subject analysis set title
    CEM
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis was performed on a per-breast basis; thus, the accuracy of L-CEM vs. CE-MRI to analyze multifocality or multicentricity was not assessed.

    Primary: Comparison

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    End point title
    		 Comparison
    End point description
    End point type
    Primary
    End point timeframe
    na
    End point values
    		 CE-MRI CEM
    Number of subjects analysed
    104
    104
    Units: number of lesions
        number (confidence interval 95%)
    93.6 (86.5 to 97.0)
    91.4 (84.1 to 95.5)
    Statistical analysis title
    		 accuracy
    Statistical analysis description
    The analysis was performed on a per-breast basis; thus, the accuracy of L-CEM vs. CE-MRI to analyze multifocality or multicentricity was not assessed.
    Comparison groups
    CE-MRI v CEM
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 day
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    all subjects
    Reporting group description
    		 -

    Serious adverse events
    		 all subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 104 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 all subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 104 (0.96%)
    Skin and subcutaneous tissue disorders
    urticria
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 104 (0.96%)
         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.
    NA
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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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