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    Clinical Trial Results:
    In vivo molecular imaging of angiogenesis after VEGF-D gene therapy

    Summary
    EudraCT number
    		 2018-001494-24
    Trial protocol
    		 DK  
    Global end of trial date
    01 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2024
    First version publication date
    16 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AK2015-10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Rasmus Ripa, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, 45 35454011, rasmus.ripa@regionh.dk
    Scientific contact
    Rasmus Ripa, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, 45 35454011, rasmus.ripa@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
    26 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To use 68Ga-NODAGA-E[c(RGDyK)]2 PET/CT scans as a tool to image myocardial angiogenesis
    Protection of trial subjects
    The study investigated a new i.v. 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
    05 Mar 2020
    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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    8
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population was recruited at a single center in Copenhagen, Denmark from March 2020 until October 2022.

    Pre-assignment
    Screening details
    		 All participants in the ReGenHeart study (2017-000789-31) recruited in Denmark were screened for inclusion.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VEGF treatment
    Arm description
    		 -
    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 use
    Dosage and administration details
    At the scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2

    Arm title
    		 Control
    Arm description
    		 -
    Arm type
    		 Placebo

    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 use
    Dosage and administration details
    At the scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2

    Number of subjects in period 1
    		VEGF treatment Control
    Started
    11
    5
    Completed
    7
    5
    Not completed
    4
    0
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    1
    -
         withdrew from ReGenHeart-treatment
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VEGF treatment
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Reporting group values
    		 VEGF treatment Control Total
    Number of subjects
    		 11 5 16
    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 (full range (min-max))
    		 66 (59 to 78) 61 (44 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1 2
        Male
    		 10 4 14

    End points

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    End points reporting groups
    Reporting group title
    VEGF treatment
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Primary: Cardiac 68Ga-RGD uptake

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    End point title
    		 Cardiac 68Ga-RGD uptake
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to 6 months after VEGF treatment
    End point values
    		 VEGF treatment Control
    Number of subjects analysed
    7
    5
    Units: RAW
        arithmetic mean (standard deviation)
    208 ( 391 )
    26 ( 430 )
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    VEGF treatment v Control
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All participants were monitored 24 hours after injection of the radiotracer for adverse events. In additon, participants were asked about potential adverse events occuring in the period between the 3 scans (3-4 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All included
    Reporting group description
    		 All subjects treated with at least one dose of IMP

    Serious adverse events
    		 All included
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (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%
    Non-serious adverse events
    		 All included
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 15 (33.33%)
    Cardiac disorders
    Vertigo
    Additional description: Self limiting
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nervous system disorders
    Headache
    Additional description: Self limiting headache during scan
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Influenza
    Additional description: Influenza-like syptoms. Self limiting
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Renal and urinary disorders
    Cystitis
    Additional description: asymptomatic
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Endocrine disorders
    Diabetes mellitus management
    Additional description: Mild dysregulation of diabetes
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    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.
    It was not possible to include the planned number of subjects.
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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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