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    Clinical Trial Results:
    Phase II trial: uPAR-PET for preoperative staging of breast cancer patients

    Summary
    EudraCT number
    		 2015-004503-23
    Trial protocol
    		 DK  
    Global end of trial date
    10 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2021
    First version publication date
    01 Jan 2021
    Other versions
    Summary report(s)
    		 Status April 4 2018
    Status December 2020 - Results

    Trial information

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    Trial identification
    Sponsor protocol code
    CS-2015-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02681640
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Professor Andreas Kjær, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, akjaer@sund.ku.dk
    Scientific contact
    Professor Andreas Kjær, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, akjaer@sund.ku.dk
    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
    04 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla
    Protection of trial subjects
    This study was conducted in accordance with International Code of Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country in which the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2016
    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
    Denmark: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    31
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 50 patients were recruited at Rigshospitalet, Copenhagen University Hospital in the period Feburary 1 2016 to February 10 2017

    Pre-assignment
    Screening details
    		 54 patients were screened and were found eligible for inclusion in the study. However, 4 patients did not receive the radioligand due to technical failure of radioligand production and were excluded from the study

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    observer-blinded readings of 68Ga-NOTA-AE105 PET/CT (two separate teams consisting of 1 experienced, board-certified specialist in Nuclear Medicine and 1 experienced, board-certified specialist in radiology

    Arms
    Arm title
    		 Experimental arm
    Arm description
    		 All included patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-NOTA-AE105
    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
    One injection of up to 200 Mbq

    Number of subjects in period 1
    		Experimental arm
    Started
    50
    Completed
    49
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Intervention (overall period) Total
    Number of subjects
    		 50 50
    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)
    		 18 18
        From 65-84 years
    		 32 32
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57 ± 13 -
    Gender categorical
    Units: Subjects
        Female
    		 49 49
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 All included patients

    Primary: Sensitivity and specificity of uPAR-PET (reader team 1)

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    End point title
    		 Sensitivity and specificity of uPAR-PET (reader team 1) [1]
    End point description
    Sensitivity and specificity for detection of lymph node metastases on a per patient basis. Sensitivity (reader team 1): 37.0% [19.4-57.6%] Specificity (reader team 1): 86.4% [65.1-97.1%]
    End point type
    Primary
    End point timeframe
    Whole study period
    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: Descriptive statistics included (95% CI) on sensitivity and specificity. No statistical differences in sensitivity (team 1: uPAR-PET/CT vs. US+FNB: p=0.56; team 2: uPAR-PET/CT vs. US+FNB p=0.18) or specificity (team 1: uPAR-PET/CT vs. US+FNB p=0.08; Team 2: uPAR-PET/CT vs. US+FNB p=0.16) were found.
    End point values
    		 Experimental arm
    Number of subjects analysed
    49
    Units: Patients
        True negative
    19
        True positive
    10
        False positive
    3
        False negative
    17
    No statistical analyses for this end point

    Primary: Sensitivity and specificity of uPAR-PET (reader team 2)

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    End point title
    		 Sensitivity and specificity of uPAR-PET (reader team 2) [2]
    End point description
    Sensitivity and specificity for detection of lymph node metastases on a per patient basis. Sensitivity (reader team 2): 29.6% [13.8-50.2%] Specificity (reader team 2): 90.9% [70.8-98.9%]
    End point type
    Primary
    End point timeframe
    Whole study period
    Notes
    [2] - 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: Descriptive statistics included (95% CI) on sensitivity and specificity. No statistical differences in sensitivity (team 1: uPAR-PET/CT vs. US+FNB: p=0.56; team 2: uPAR-PET/CT vs. US+FNB p=0.18) or specificity (team 1: uPAR-PET/CT vs. US+FNB p=0.08; Team 2: uPAR-PET/CT vs. US+FNB p=0.16) were found.
    End point values
    		 Experimental arm
    Number of subjects analysed
    49
    Units: Patients
        True negative
    20
        True positive
    8
        False positive
    2
        False negative
    19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    ??? 2016 -10 Feb 2017
    Adverse event reporting additional description
    Events was considered as related to the IMP if they occurred during the period from the time of injection of the tracer and up to 24 hours after the injection. Events / Adverse reactions occurring later than 24 hours after injection was not registered.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    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 non-serious adverse events were reported. This was as expected, as 68Ga-NOTA-AE105 has no known adverse effects
    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Anaphylactic reaction
    Additional description: One patient developed anaphylactoid reactions to iodinated CT contrast media. The reaction started within 30 seconds after administration of the iodinated contrast media.
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)

    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.
    None reported
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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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