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    Clinical Trial Results:
    Phase II: 68Ga-NODAGA-E[c(RGDyK)]2 Angiogenese PET for imaging angiogenesis in ST-Elevation Myocardial Infarction(STEMI)

    Summary
    EudraCT number
    		 2017-002709-36
    Trial protocol
    		 DK  
    Global end of trial date
    09 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2021
    First version publication date
    21 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AK2017-3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03445884
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Simon Bentsen, Rigshospitalet, Department og Clinical Physiology, Nuclear Medicine and PET, 0045 35451793, simon.bentsen.01@regionh.dk
    Scientific contact
    Simon Bentsen, Rigshospitalet, Department og Clinical Physiology, Nuclear Medicine and PET, 0045 35451793, simon.bentsen.01@regionh.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
    05 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to test a new radio tracer called 68Ga-NODAGA-E-[RGDyK]2 for PET imaging of angiogenesis. The tracer has the potential of identifying heart tissue with a high level of angiogenesis. Angiogenesis is a very important factor in reparing heart tissue after an heartattack. therefor, the tracer can potentially be used to asses how the tissue respons to the chosen therapy.
    Protection of trial subjects
    The study investigated a new radiotracer for detecting angiogenesis. There were no discomfort or pain associated with the study of the new tracer.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 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: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    23
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients admitted to the department of cardiology that were diagnosed with ST-elevation myocardial infarction, were screened after admission.

    Pre-assignment
    Screening details
    		 All patients with STEMI were screened before enrollment in the study by a physician. The inclusion criteria were : STEMI-group: > 50 years of age with verified STEMI, control group: >18 years with no recording of disease.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 STEMI
    Arm description
    		 The STEMI group was PET/CT scanned with RGD-PET acute, after one week and after four weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-NODAGA-E[c(RGDyK)]2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    At each scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2

    Arm title
    		 Control group
    Arm description
    		 -
    Arm type
    		 healthy control group

    Investigational medicinal product name
    68Ga-NODAGA-E[c(RGDyK)]2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    At each scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2

    Number of subjects in period 1
    		STEMI Control group
    Started
    37
    5
    Completed
    32
    5
    Not completed
    5
    0
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 42 42
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 23 23
        From 65-84 years
    		 19 19
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 32 32

    End points

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    End points reporting groups
    Reporting group title
    STEMI
    Reporting group description
    		 The STEMI group was PET/CT scanned with RGD-PET acute, after one week and after four weeks

    Reporting group title
    Control group
    Reporting group description
    		 -

    Primary: RGD-PET uptake in the myocardium acute

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    End point title
    		 RGD-PET uptake in the myocardium acute [1]
    End point description
    End point type
    Primary
    End point timeframe
    The SUV uptake in the infarcted area after the acute scan
    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: It is not possible to report the paired t-test result between mean SUV uptake in the infarcted area and healthy myocardium. Therefore, the results of these data will be available in the pending manuscript.
    End point values
    		 STEMI Control group
    Number of subjects analysed
    36
    5
    Units: gram(s)/millilitre
        median (standard deviation)
    1.43 ± 0.37
    1.15 ± 0.12
    No statistical analyses for this end point

    Primary: RGD-PET uptake in the myocardium after one week

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    End point title
    		 RGD-PET uptake in the myocardium after one week [2] [3]
    End point description
    End point type
    Primary
    End point timeframe
    The SUV uptake in the infarcted area after one week.
    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: It is not possible to report the paired t-test result between mean SUV uptake in the infarcted area and healthy myocardium. Therefore, the results of these data will be available in the pending manuscript.
    [3] - 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: It is not possible to report the paired t-test result between mean SUV uptake in the infarcted area and healthy myocardium. Therefore, the results of these data will be available in the pending manuscript.
    End point values
    		 STEMI
    Number of subjects analysed
    30
    Units: gram(s)/millilitre
        median (standard deviation)
    2.1 ± 0.46
    No statistical analyses for this end point

    Primary: RGD-PET uptake in the myocardium after four weeks

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    End point title
    		 RGD-PET uptake in the myocardium after four weeks [4] [5]
    End point description
    End point type
    Primary
    End point timeframe
    The SUV uptake in the infarcted area after four weeks
    Notes
    [4] - 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: It is not possible to report the paired t-test result between mean SUV uptake in the infarcted area and healthy myocardium. Therefore, the results of these data will be available in the pending manuscript.
    [5] - 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: It is not possible to report the paired t-test result between mean SUV uptake in the infarcted area and healthy myocardium. Therefore, the results of these data will be available in the pending manuscript.
    End point values
    		 STEMI
    Number of subjects analysed
    31
    Units: gram(s)/millilitre
        median (standard deviation)
    2.04 ± 0.56
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All participants were monitored 48 hours after injection of the radiotracer.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    STEMI
    Reporting group description
    		 The STEMI group was PET/CT scanned with RGD-PET acute, after one week and after four weeks

    Reporting group title
    Control group
    Reporting group description
    		 In the healthy controlgroup the person were PET/CT scanned one time with RGD-PET.

    Serious adverse events
    		 STEMI Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 5 (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
    		 STEMI Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 5 (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: There were no adverse event in this study.

    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
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