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    Clinical Trial Results:
    MAGnetic versus STAndard technique for sentinel node biopsy in breast cancer compared in a Randomised controlled trial

    Summary
    EudraCT number
    		 2015-000549-21
    Trial protocol
    		 GB  
    Global end of trial date
    20 Feb 2017

    Results information
    Results version number
    		 v1
    This version publication date
    04 Oct 2019
    First version publication date
    04 Oct 2019
    Other versions
    		 v2
    Summary report(s)
    		 Cancelled Before Active Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    MAGSTAR
    Additional study identifiers
    ISRCTN number
    		 ISRCTN20200149
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1164-0844
    Other trial identifiers
    		 Trialregister.nl (Dutch registration): Pending
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Mr Michael Douek, King's College London, 44 2071886380, michael.douek@kcl.ac.uk
    Scientific contact
    Mr Michael Douek, King's College London, 44 2071886380, michael.douek@kcl.ac.uk
    Sponsor organisation name
    Guy's & St Thomas' NHS Foundation Trust
    Sponsor organisation address
    F16 Tower Wing, Guy's Hospital, Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Mr Michael Douek, Guy's and St Thomas' NHS Foundation Trust, 44 2071886380, michael.douek@kcl.ac.uk
    Scientific contact
    Mr Michael Douek, Guy's and St Thomas' NHS Foundation Trust, 2071885732 2071886380, michael.douek@kcl.ac.uk
    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
    20 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the magnetic technique (involving the magnetic tracer and magnetometer) can be used instead of the standard 'dual' technique (blue dye and radioactive injection) to locate lymph nodes during breast cancer surgery.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Feb 2017
    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
    United Kingdom: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Nanocoll
    Arm description
    		 Nanocoll 0.3 ml
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nanocoll
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosage would have been one injection 0.3 ml subcutaneously

    Number of subjects in period 1
    		Nanocoll
    Started
    99999
    Completed
    99999

    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
    		 99999 99999
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Nanocoll
    Reporting group description
    		 Nanocoll 0.3 ml

    Primary: Overall SLNB identification rate

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    End point title
    		 Overall SLNB identification rate [1]
    End point description
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Primary
    End point timeframe
    N/A
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No subjects were enrolled in the trial hence results are not available
    End point values
    		 Nanocoll
    Number of subjects analysed
    99999 [2]
    Units: 0
        number (not applicable)
    99999
    Notes
    [2] - No subjects were enrolled in the trial hence results are not available
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of the clinical trial were to be collected.
    Adverse event reporting additional description
    N/A
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Nanocoll
    Reporting group description
    		 Nanocoll 0.3 ml

    Serious adverse events
    		 Nanocoll
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nanocoll
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subjects were enrolled in the trial hence results are not available

    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.
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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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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