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    Clinical Trial Results:
    64Cu-DOTATATE PET/CT-skanning to diagnose macrophage infiltation in the heart valves of patients with infectiv endocarditis.

    Summary
    EudraCT number
    		 2021-005501-27
    Trial protocol
    		 DK  
    Global end of trial date
    29 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2025
    First version publication date
    07 Mar 2025
    Other versions
    Summary report(s)
    		 published article

    Trial information

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    Trial identification
    Sponsor protocol code
    80843
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05432427
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigs
    Sponsor organisation address
    Blegdamsvej 9, copenhagen, Denmark, 2100
    Public contact
    Department of Cardiology, Rigshospitalet, 0045 35454885, katra.hadji-turdeghal@regionh.dk
    Scientific contact
    Department of Cardiology, Rigshospitalet, 0045 35456340, emil.fosboel@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
    29 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We hypothesize that the 64Cu-DOTATATE will show uptake in the infected vegetations on the prosthetic heart valves and increase the accuracy of the right diagnosis – thus increasing the sensitivity and specificity compared to 18F-FDG PET/CT
    Protection of trial subjects
    According to CGP guidelines
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2022
    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: 69
    Worldwide total number of subjects
    69
    EEA total number of subjects
    69
    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)
    48
    From 65 to 84 years
    20
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were included at the Departmet of Cardiology, Rigshospitalet, Copenhagen, Denmark according to inclusion and exclusion criteria as described

    Pre-assignment
    Screening details
    		 In total 99 patients were screened

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

    Arms
    Arm title
    		 scans
    Arm description
    		 64Cu]Cu-DOTATATE and [ 18F]FDG PET/CT were performed,using established methods at the Department of ClinicalPhysiology and Nuclear Medicine at Copenhagen University Hospital, Rigshospitalet. The scans were scheduled to be per-formed in a random order after diagnosis and not more than seven days between the two scans. Because of the differenteffective half-life of the tracers, [ 18F]FDG PET/CT could be performed no earlier than 48 hours after [64Cu]Cu-DOTATATEPET/CT. If the [ 18F]FDG PET/CT scan was performed first, at least 12 hours had to pass before the subsequent [64Cu]Cu-DOTATATE PET/CT could be performed
    Arm type
    		 scan

    Investigational medicinal product name
    64Cu-DOTATATE
    Investigational medicinal product code
    SUB181362
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 MBq(+/- 10%)/ml one time administration

    Number of subjects in period 1
    		scans
    Started
    69
    Completed
    69

    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
    		 69 69
    Age categorical
    Cases: 68.0 [IQR 55.0-75.5] Controls 60.5 [IQR 57.0-69.5]
    Units: Subjects
        Cases
    		 49 49
        Controls
    		 20 20
    Gender categorical
    Cases: sex (male, n (%)): 17 ( 85.0%) Controls: (male, n (%)): 14 (70.0%)
    Units: Subjects
        Female
    		 17 17
        Male
    		 52 52
    Subject analysis sets

    Subject analysis set title
    the main study
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The sensitivity and specificity of [64Cu]Cu-DOTATATEPET/CT in the 20 cases and the 20 controls were 55%(95% CI, 33–77) and 90% (95% CI, 77–100), respec-tively. This corresponded to a PPV of 85% (95% CI,65–100) and an NPV of 67% (95% CI, 49–84) in oursample with a prevalence of 50% The sensitivity and specificity of [ 18F]FDG PET/CT inthe 20 cases and the 20 controls were 55% (95% CI,33–77) and 75% (95% CI, 56–94), respectively. Thiscorresponded to a positive predictive value (PPV) of69% (95% CI, 46–91) and a negative predictive value(NPV) of 63% (95% CI, 43–82)

    Subject analysis sets values
    		 the main study
    Number of subjects
    40
    Age categorical
    Cases: 68.0 [IQR 55.0-75.5] Controls 60.5 [IQR 57.0-69.5]
    Units: Subjects
        Cases
    20
        Controls
    20
    Age continuous
    Cases: 68.0 [IQR 55.0-75.5] Controls 60.5 [IQR 57.0-69.5]
    Units: years
        median (inter-quartile range (Q1-Q3))
    Gender categorical
    Cases: sex (male, n (%)): 17 ( 85.0%) Controls: (male, n (%)): 14 (70.0%)
    Units: Subjects
        Female
    9
        Male
    31

    End points

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    End points reporting groups
    Reporting group title
    scans
    Reporting group description
    		 64Cu]Cu-DOTATATE and [ 18F]FDG PET/CT were performed,using established methods at the Department of ClinicalPhysiology and Nuclear Medicine at Copenhagen University Hospital, Rigshospitalet. The scans were scheduled to be per-formed in a random order after diagnosis and not more than seven days between the two scans. Because of the differenteffective half-life of the tracers, [ 18F]FDG PET/CT could be performed no earlier than 48 hours after [64Cu]Cu-DOTATATEPET/CT. If the [ 18F]FDG PET/CT scan was performed first, at least 12 hours had to pass before the subsequent [64Cu]Cu-DOTATATE PET/CT could be performed

    Subject analysis set title
    the main study
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The sensitivity and specificity of [64Cu]Cu-DOTATATEPET/CT in the 20 cases and the 20 controls were 55%(95% CI, 33–77) and 90% (95% CI, 77–100), respec-tively. This corresponded to a PPV of 85% (95% CI,65–100) and an NPV of 67% (95% CI, 49–84) in oursample with a prevalence of 50% The sensitivity and specificity of [ 18F]FDG PET/CT inthe 20 cases and the 20 controls were 55% (95% CI,33–77) and 75% (95% CI, 56–94), respectively. Thiscorresponded to a positive predictive value (PPV) of69% (95% CI, 46–91) and a negative predictive value(NPV) of 63% (95% CI, 43–82)

    Primary: primary

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    End point title
    		 primary
    End point description
    End point type
    Primary
    End point timeframe
    April 2022 through June 2023,
    End point values
    		 scans the main study
    Number of subjects analysed
    69
    40
    Units: 55%
    69
    40
    Attachments
    		 published article
    Statistical analysis title
    		 64Cu-DOTATATE
    Statistical analysis description
    To assess differences in SUVmax uptake between groups for [64Cu]Cu-DOTATATE and [18F] FDG PET/CT respectively, unpaired Wilcoxon rank tests were applied.
    Comparison groups
    scans v the main study
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.008 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Cases vs controls 64Cu-DOTATATE
    [2] - For CuDOTATATE
    Statistical analysis title
    		 18F-FDG
    Comparison groups
    scans v the main study
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    April 2022 to april 2024 no serious adverse events have been reported. Only 8 participatns experienced transient symptoms after administration of the injection.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 69 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 69 (11.59%)
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Transient diarrhoea
         subjects affected / exposed
    3 / 69 (4.35%)
         occurrences all number
    3
    Nausea
    Additional description: Transient nausau after the injection
         subjects affected / exposed
    2 / 69 (2.90%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Flushing
    Additional description: 2
         subjects affected / exposed
    2 / 69 (2.90%)
         occurrences all number
    2
    Headache
    Additional description: Headache short term
         subjects affected / exposed
    1 / 69 (1.45%)
         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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39902600
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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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