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    Clinical Trial Results:
    PET/CT imaging of uPAR-expression in patients with neuroendocrine tumors using 68Ga-NOTA-AE105

    Summary
    EudraCT number
    		 2017-002312-13
    Trial protocol
    		 DK  
    Global end of trial date
    08 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2022
    First version publication date
    17 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AK2017-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03278275
    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, 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, 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
    08 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In this study with uPAR PET we include patients diagnosed with neuroendocrine tumors in order to investigate the tumor visualization and prognostic performance of (68Ga-NOTA-AE105) uPAR PET/CT
    Protection of trial subjects
    It is emphasized that participation in the study is voluntary and will have no influence on the otherwise planned treatment, whether the patient will participate or not. The study is conducted in accordance with the Helsinki Declaration and the Good Clinical Practice (GCP). All clinical information about the participants is protected under the act on processing of Personal Data and the Danish Health Legislation. Overall, it is considered that the project is ethically sound, as there are no significant risks associated with the uPAR PET/CT imaging procedure.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    Denmark: 116
    Worldwide total number of subjects
    116
    EEA total number of subjects
    116
    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)
    47
    From 65 to 84 years
    69
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Prospective inclusion patients with lung or gastro-entero-pancreatic neuroendocrine neoplasms.

    Pre-assignment
    Screening details
    		 We prospectively included 116 patients who fullfilled inclusion and exclusion criteria. Of the 116, 17 did not undergo uPAR PET/CT (worsening of disease, n=5; withdrawal of consent, n=5; death before uPAR PET/CT, n=4; impossibility of performing uPAR PET/CT because of coronavirus disease 2019 restrictions, n=3).

    Pre-assignment period milestones
    Number of subjects started
    		 116
    Number of subjects completed
    		 116

    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
    An experienced board-certified nuclear medicine physician together with an experienced board-certified radiologist analyzed side by side the PET/CT scans. The readers were masked to patient data.

    Arms
    Arm title
    		 Experimental arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-NOTA-AE105
    Investigational medicinal product code
    SUB271580 - [68Ga]Ga-NOTA-AE105
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    One injection of up to 236 MBq 68Ga-NOTA-AE105

    Number of subjects in period 1
    		Experimental arm
    Started
    116
    Completed
    99
    Not completed
    17
         Consent withdrawn by subject
    5
         worsening of disease
    5
         COVID 19 impossibility of performing uPAR PET/CT
    3
         death before uPAR PET/CT
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All patients fullfilling the inclusion/exclusion criteria and included in the study

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 116 116
    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
        median (full range (min-max))
    		 67 (34 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 49 49
        Male
    		 67 67
    Subject analysis sets

    Subject analysis set title
    Primary analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who underwent uPAR PET/CT and had evaluable lesions (visible lesions on PET and or CT)

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who underwent uPAR PET/CT

    Subject analysis set title
    Secondary analyses set - low uPAR
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients were dicotomized by tumor uPAR uptake in a group of low and high uptake

    Subject analysis set title
    Secondary analyses set - high uPAR
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients were dicotomized (by median) by their tumor uPAR uptake in low and high uptake

    Subject analysis sets values
    		 Primary analysis set Safety set Secondary analyses set - low uPAR Secondary analyses set - high uPAR
    Number of subjects
    96
    99
    48
    48
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    66 (34 to 82)
    66 (34 to 82)
    63 (48 to 78)
    70 (34 to 82)
    Gender categorical
    Units: Subjects
        Female
    39
    41
    20
    19
        Male
    57
    58
    28
    29

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 -

    Subject analysis set title
    Primary analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who underwent uPAR PET/CT and had evaluable lesions (visible lesions on PET and or CT)

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who underwent uPAR PET/CT

    Subject analysis set title
    Secondary analyses set - low uPAR
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients were dicotomized by tumor uPAR uptake in a group of low and high uptake

    Subject analysis set title
    Secondary analyses set - high uPAR
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients were dicotomized (by median) by their tumor uPAR uptake in low and high uptake

    Primary: uPAR PET-positive tumors

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    End point title
    		 uPAR PET-positive tumors [1]
    End point description
    End point type
    Primary
    End point timeframe
    Assessed following the performance of uPAR PET
    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 analysis of the number of patients with uPAR positive lesions
    End point values
    		 Primary analysis set
    Number of subjects analysed
    96
    Units: number of patients
        Positive
    65
        Negative
    31
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    During at least 1 year follow-up after uPAR PET/CT
    End point values
    		 Primary analysis set Secondary analyses set - low uPAR Secondary analyses set - high uPAR
    Number of subjects analysed
    96
    48
    48
    Units: number of patients
        Progressive disease
    59
    23
    36
        Non-progressive disease
    37
    25
    12
    Statistical analysis title
    		 Cox regression analysis
    Comparison groups
    Secondary analyses set - low uPAR v Secondary analyses set - high uPAR
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 3.17

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    At least one year follow-up after uPAR PET/CT
    End point values
    		 Primary analysis set Secondary analyses set - low uPAR Secondary analyses set - high uPAR
    Number of subjects analysed
    96
    48
    48
    Units: number of patients
        Dead
    28
    9
    19
        Alive
    68
    39
    29
    Statistical analysis title
    		 Cox regression analysis
    Comparison groups
    Secondary analyses set - low uPAR v Secondary analyses set - high uPAR
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.19
         upper limit
    		 5.88
    Notes
    [2] - Patients were dichotomized by median values

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 24 hours of uPAR PET/CT
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    All patients scanned
    Reporting group description
    		 All patients who underwent uPAR PET/CT

    Serious adverse events
    		 All patients scanned
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 All patients scanned
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 99 (1.01%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2018
    New principal investigator

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35058319
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