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    Clinical Trial Results:
    Diagnosing Wilson’s Disease with 64-Cu PET/MR – A Pilot Study

    Summary
    EudraCT number
    		 2021-005464-21
    Trial protocol
    		 DK  
    Global end of trial date
    01 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2023
    First version publication date
    22 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DiagnosingWD-PET/MR-pilot
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard, Aarhus N, Denmark, 8200
    Public contact
    Department of Hepatology, Aarhus University Hospital, levermavetarm@auh.rm.dk
    Scientific contact
    Department of Hepatology, Aarhus University Hospital, levermavetarm@auh.rm.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 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We wish to optimize the diagnostic potential of 64Cu PET in Wilson's disease by determining the optimal time point for the scan following tracer injection.
    Protection of trial subjects
    Safety data monitored until 14 days after the last scan.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Aug 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: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    14
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included through the outpatient clinic. Heterozygote relatives were siblings or parents of patients and were recruited through the patient association. Healthy individuals were recruited through advertisements in our own department.

    Pre-assignment
    Screening details
    		 Patients were screened by their physician. Heterozygotes were known carriers of the gene (sibling with gene analysis or parents). Both controls and heterozygotes were screened by an array of standard blood samples (i.e., electrolytes, INR, hemoglobin, leukocytes, CRP, ALT, Bilirubin, creatinine) that had to be within normal range for the inclusion.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 WD patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    64CuCl2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Approximately 75 MBq in an intravenous injection

    Arm title
    		 Heterozygotes
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Controls
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		WD patients Heterozygotes Controls
    Started
    5
    5
    5
    Completed
    5
    5
    5

    Baseline characteristics

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

    Reporting group values
    		 Baseline characteristics Total
    Number of subjects
    		 15 15
    Age categorical
    Median age (quartiles)
    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)
    		 14 14
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Median age (range)
    Units: years
        median (full range (min-max))
    		 38 (23 to 66) -
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 6 6
        Male
    		 9 9

    End points

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    End points reporting groups
    Reporting group title
    WD patients
    Reporting group description
    		 -

    Reporting group title
    Heterozygotes
    Reporting group description
    		 -

    Reporting group title
    Controls
    Reporting group description
    		 -

    Primary: Liver SUV 20 hours

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    End point title
    		 Liver SUV 20 hours
    End point description
    End point type
    Primary
    End point timeframe
    End-of-trial
    End point values
    		 WD patients Heterozygotes Controls
    Number of subjects analysed
    5
    5
    5
    Units: SUV (unitless)
        arithmetic mean (standard deviation)
    33.78 ± 5.34
    31.27 ± 2.67
    20.08 ± 2.71
    Statistical analysis title
    		 One-way ANOVA
    Comparison groups
    Heterozygotes v Controls v WD patients
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0002
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - Group difference

    Primary: Liver SUV 48 hours

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    End point title
    		 Liver SUV 48 hours
    End point description
    End point type
    Primary
    End point timeframe
    End-of-trial
    End point values
    		 WD patients Heterozygotes Controls
    Number of subjects analysed
    5
    5
    5
    Units: SUV (unitless)
        arithmetic mean (standard deviation)
    38.28 ± 6.4
    32.29 ± 5.21
    18.00 ± 3.48
    Statistical analysis title
    		 One-way ANOVA
    Comparison groups
    WD patients v Heterozygotes v Controls
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5
    Method
    		 ANOVA
    Confidence interval

    Primary: Liver SUV 54 hours

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    End point title
    		 Liver SUV 54 hours
    End point description
    End point type
    Primary
    End point timeframe
    End-of-trial
    End point values
    		 WD patients Heterozygotes Controls
    Number of subjects analysed
    5
    5
    5
    Units: SUV (unitless)
        arithmetic mean (standard deviation)
    38.44 ± 5.18
    29.44 ± 3.25
    17.10 ± 2.98
    Statistical analysis title
    		 One-way ANOVA
    Comparison groups
    WD patients v Heterozygotes v Controls
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7
    Method
    		 ANOVA
    Confidence interval

    Primary: Liver SUV 68 hours

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    End point title
    		 Liver SUV 68 hours
    End point description
    End point type
    Primary
    End point timeframe
    End-of-trial
    End point values
    		 WD patients Heterozygotes Controls
    Number of subjects analysed
    5
    5
    5
    Units: SUV (unitless)
        arithmetic mean (standard deviation)
    36.59 ± 6.72
    29.63 ± 2.34
    15.50 ± 2.60
    Statistical analysis title
    		 One-way ANOVA
    Comparison groups
    WD patients v Heterozygotes v Controls
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3
    Method
    		 ANOVA
    Confidence interval

    Primary: Gallbladder SUV 20 hours

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    End point title
    		 Gallbladder SUV 20 hours
    End point description
    End point type
    Primary
    End point timeframe
    End-of-trial
    End point values
    		 WD patients Heterozygotes Controls
    Number of subjects analysed
    4 [2]
    5
    5
    Units: SUV (unitless)
        arithmetic mean (standard deviation)
    2.87 ± 0.75
    9.01 ± 2.98
    32.80 ± 9.19
    Notes
    [2] - One had had the gallbladder removed
    Statistical analysis title
    		 One-way ANOVA
    Comparison groups
    WD patients v Heterozygotes v Controls
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Confidence interval

    Primary: Gallbladder SUV 48 hours

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    End point title
    		 Gallbladder SUV 48 hours
    End point description
    End point type
    Primary
    End point timeframe
    End-of-trial
    End point values
    		 WD patients Heterozygotes Controls
    Number of subjects analysed
    4 [3]
    4 [4]
    5
    Units: SUV (unitless)
        arithmetic mean (standard deviation)
    2.63 ± 0.84
    6.39 ± 1.66
    11.40 ± 4.19
    Notes
    [3] - One had had the gallbladder removed
    [4] - One where the gallbladder was not visible on scan (collapsed)
    Statistical analysis title
    		 One-way ANOVA
    Comparison groups
    WD patients v Heterozygotes v Controls
    Number of subjects included in analysis
    13
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 ANOVA
    Confidence interval

    Primary: Gallbladder SUV 54 hours

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    End point title
    		 Gallbladder SUV 54 hours
    End point description
    End point type
    Primary
    End point timeframe
    End-of-trial
    End point values
    		 WD patients Heterozygotes Controls
    Number of subjects analysed
    4 [5]
    4 [6]
    4 [7]
    Units: SUV (unitless)
        arithmetic mean (standard deviation)
    2.60 ± 0.47
    4.48 ± 4.13
    8.72 ± 5.57
    Notes
    [5] - One had had the gallbladder removed
    [6] - One where the gallbladder was not visible on the scan (collapsed)
    [7] - One where the gallbladder was not visible on the scan (collapsed)
    Statistical analysis title
    		 One-way ANOVA
    Comparison groups
    WD patients v Heterozygotes v Controls
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2
    Method
    		 ANOVA
    Confidence interval

    Primary: Gallbladder SUV 68 hours

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    End point title
    		 Gallbladder SUV 68 hours
    End point description
    End point type
    Primary
    End point timeframe
    End-of-trial
    End point values
    		 WD patients Heterozygotes Controls
    Number of subjects analysed
    4 [8]
    3 [9]
    4 [10]
    Units: SUV (unitless)
        arithmetic mean (standard deviation)
    2.74 ± 0.75
    3.36 ± 1.57
    13.68 ± 5.10
    Notes
    [8] - One had had the gallbladder removed
    [9] - Two where the gallbladder was not visible on the scan (collapsed)
    [10] - One where the gallbladder was not visible on the scan (collapsed)
    Statistical analysis title
    		 One-way ANOVA
    Comparison groups
    WD patients v Heterozygotes v Controls
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0013
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    14 days after last scan
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.1
    Reporting groups
    Reporting group title
    All groups
    Reporting group description
    		 -

    Serious adverse events
    		 All groups
    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: 1%
    Non-serious adverse events
    		 All groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 15 (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 events (serious or non-serious) in the 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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