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    Clinical Trial Results:
    Phase II trial: uPAR PET/CT and FDG PET/MRI for preoperative staging of bladder cancer

    Summary
    EudraCT number
    		 2016-001026-33
    Trial protocol
    		 DK  
    Global end of trial date
    04 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2021
    First version publication date
    03 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AK2016-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02805608
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Professor Andreas Kjaer, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, akjaer@sund.ku.dk
    Scientific contact
    Professor Andreas Kjaer, 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
    18 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MR for detection of regional lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative procedure. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection based on 6 regions. The suspected lymph nodes will be assigned to 6 regions based on the images. During the following operation the lymph nodes will be removed and analysed in each of these regions.
    Protection of trial subjects
    An experienced medical doctor will be present in the department during the entire duration of the PET/CT and PET/MR scans. Emergency equipment is available in accordance with the current procedures of the department, including cardiopulmonary resuscitation and oxygen supply/suction. It is emphasized, that handling of emergency situations is part of the department's routine procedures, and the staff is trained to handle e.g. unexpected allergic reactions associated with administration of CT contrast agents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2016
    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
    Denmark: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    6
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from 10 DEC 2016 to 04 DEC 2017. All patients were recruited from Rigshospitalet, Denmark.

    Pre-assignment
    Screening details
    		 Screening performed by a medical doctor according to the inclusion and exclusion criteria

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Experimental: uPAR PET/CT
    Arm description
    		 Subjects injected with [68Ga]-NOTA-AE105 and subsequently scanned with PET/CT (uPAR PET/CT)
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]-NOTA-AE105
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Dose of approximately 200 MBq (40 µg) administered intra-venously approximately 20 minutes prior to the PET/CT

    Arm title
    		 Experimental: FDG PET/MR
    Arm description
    		 Subjects injected with [18F]-FDG and subsequently scanned with PET/MR (FDG PET/MR)
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]-FDG
    Investigational medicinal product code
    Other name
    2-Deoxy-2-[18F]fluoroglucose
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Dose of approximately 200 MBq administered intra-venously approximately 1 hour prior PET/MR

    Number of subjects in period 1
    		Experimental: uPAR PET/CT Experimental: FDG PET/MR
    Started
    14
    11
    Completed
    14
    10
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    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
    		 18 18
    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)
    		 6 6
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.3 ( 8.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 13 13

    End points

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    End points reporting groups
    Reporting group title
    Experimental: uPAR PET/CT
    Reporting group description
    		 Subjects injected with [68Ga]-NOTA-AE105 and subsequently scanned with PET/CT (uPAR PET/CT)

    Reporting group title
    Experimental: FDG PET/MR
    Reporting group description
    		 Subjects injected with [18F]-FDG and subsequently scanned with PET/MR (FDG PET/MR)

    Primary: Sensitivity in detection of regional lymph node metastases

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    End point title
    		 Sensitivity in detection of regional lymph node metastases [1] [2]
    End point description
    Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT
    End point type
    Primary
    End point timeframe
    Evaluated on the uPAR PET/CT 20 minutes after injection of [68Ga]-NOTA-AE105
    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: uPAR-PET Image technical check following 18 patients, demonstrated that bladder cancer/lymph node metastases could not be discriminated from spillover caused by high bladder activity. Accordingly, the study was terminated prematurely.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The sensitivity for detection of regional lymph node metastases was also not performed for FDG PET/MR because the main purpose of the trial was to study the sensitivity of uPAR PET/CT. For technical reasons, this was not possible and the study was terminated prematurely. The number of included subjects at termination was too low for any meaningful analysis of FDG PET/MR sensitivity.
    End point values
    		 Experimental: uPAR PET/CT
    Number of subjects analysed
    0 [3]
    Units: patients
        True positive
        False positive
        True negative
        False negative
    Notes
    [3] - Analysis not possible due to bladder spillover
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event are recorded from injection of IMP up to 24 hours after injection.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Experimental: uPAR PET/CT
    Reporting group description
    		 Subjects injected with [68Ga]-NOTA-AE105 and subsequently scanned with PET/CT (uPAR PET/CT)

    Reporting group title
    FDG PET/MR
    Reporting group description
    		 Subjects injected with [18F]-FDG and subsequently scanned with PET/MR (FDG PET/MR)

    Serious adverse events
    		 Experimental: uPAR PET/CT FDG PET/MR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental: uPAR PET/CT FDG PET/MR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
    General disorders and administration site conditions
    Claustrophobia
    Additional description: Subject experienced claustrophobia and could not continue with the FDG PET/MR scan. Adverse event was not considered related to the IMP ([18F]-FDG)
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2016
    Change in production method of [68Ga]-NOTA-AE105

    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.
    uPAR-PET Image technical check following 18 patients, demonstrated that bladder cancer/lymph node metastases could not be discriminated from spillover caused by high bladder activity. Accordingly, the study was terminated prematurely.
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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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