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    Clinical Trial Results:
    Determination of renal blood flow based on Rubidium-82 and PET-technology in healthy volunteers

    Summary
    EudraCT number
    		 2016-004080-39
    Trial protocol
    		 DK  
    Global end of trial date
    28 May 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 May 2022
    First version publication date
    09 Oct 2020
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set

    Trial information

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    Trial identification
    Sponsor protocol code
    SL-1-2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medicinsk Forskning
    Sponsor organisation address
    Lægårdvej 12, Holstebro, Denmark, 7500
    Public contact
    Stine Langaa, Medicinsk Forskning, Regionshospitalet Holstebro, Hospitalsenheden Vest, 0045 78436587, stinlg@rm.dk
    Scientific contact
    Jesper Nørgaard Bech, Medicinsk Forskning, Regionshospitalet Holstebro, Hospitalsenheden Vest, 78436587 78436787, jesper.noergaard.bech@vest.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
    17 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To develop a new and reliable method to determine renal blood flow based on Rubidium-82 and PET-technology using a 1-tissue compartment model
    Protection of trial subjects
    No specific measures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited by advertisement, primarily at local educational institutions.

    Pre-assignment
    Screening details
    		 Prior to inclusion, each participant completed a screening program. Screening consisted of a medical history; a clinical examination including measurements of weight, height, and blood pressure; electrocardiography; blood tests; urine dipstick

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Two bed positions
    Arm description
    		 Subjects were scanned in two different bed positions and hereby in two different fields of view.
    Arm type
    		 Scan order

    Investigational medicinal product name
    Rubidium-cloride-82
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Radionuclide generator
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    555 MBq pr. bolus injection. 4 bolus injections in total

    Number of subjects in period 1
    		Two bed positions
    Started
    20
    Completed
    18
    Not completed
    2
         Consent withdrawn by subject
    2

    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
    		 20 20
    Age categorical
    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)
    		 20 20
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Two bed positions
    Reporting group description
    		 Subjects were scanned in two different bed positions and hereby in two different fields of view.

    Primary: K1 - right kidney - Input function: Left ventricular blood pool

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    End point title
    		 K1 - right kidney - Input function: Left ventricular blood pool [1]
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB.
    End point type
    Primary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    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: The result is a mean value with a standard deviation
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: ml/min/g
        arithmetic mean (standard deviation)
    2.75 ± 0.42
    No statistical analyses for this end point

    Primary: K1 - left kidney - Input function: Left ventricular blood pool

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    End point title
    		 K1 - left kidney - Input function: Left ventricular blood pool [2]
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB.
    End point type
    Primary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    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: The result is a mean value with a standard deviation
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: ml/min/g
        arithmetic mean (standard deviation)
    2.71 ± 0.42
    No statistical analyses for this end point

    Primary: K1 - right kidney - Input function: Abdominal aorta. FOVA

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    End point title
    		 K1 - right kidney - Input function: Abdominal aorta. FOVA [3]
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB.
    End point type
    Primary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    Notes
    [3] - 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: The result is a mean value with a standard deviation
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: ml/min/g
        arithmetic mean (standard deviation)
    2.86 ± 0.48
    No statistical analyses for this end point

    Primary: K1 - left kidney - Input function: abdominal aorta. FOVA

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    End point title
    		 K1 - left kidney - Input function: abdominal aorta. FOVA [4]
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB.
    End point type
    Primary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    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: The result is a mean value with a standard deviation
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: ml/min/g
        arithmetic mean (standard deviation)
    2.82 ± 0.45
    No statistical analyses for this end point

    Primary: K1 - right kidney - Input function: Abdominal aorta. FOVB

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    End point title
    		 K1 - right kidney - Input function: Abdominal aorta. FOVB [5]
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB.
    End point type
    Primary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    Notes
    [5] - 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: The result is a mean value with a standard deviation
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: ml/min/g
        arithmetic mean (standard deviation)
    2.82 ± 0.45
    No statistical analyses for this end point

    Primary: K1 - left kidney - Input function: abdominal aorta. FOVB

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    End point title
    		 K1 - left kidney - Input function: abdominal aorta. FOVB [6]
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB.
    End point type
    Primary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    Notes
    [6] - 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: The result is a mean value with a standard deviation
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: ml/min/g
        arithmetic mean (standard deviation)
    2.79 ± 0.42
    No statistical analyses for this end point

    Secondary: Intra-assay coefficient of variation. Renal blood flow (K1) - right kidney - inout function: Left ventricular blood pool

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    End point title
    		 Intra-assay coefficient of variation. Renal blood flow (K1) - right kidney - inout function: Left ventricular blood pool
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB. Intra-assay coefficients of variation were calculated for each input function for each kidney based on duplicate K1 determinations in each FOV.
    End point type
    Secondary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: percent
        number (not applicable)
    5.6
    No statistical analyses for this end point

    Secondary: Intra-assay coefficient of variation. left kidney - input function: Left ventricular blood pool

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    End point title
    		 Intra-assay coefficient of variation. left kidney - input function: Left ventricular blood pool
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB. Intra-assay coefficients of variation were calculated for each input function for each kidney based on duplicate K1 determinations in each FOV.
    End point type
    Secondary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: percent
        number (not applicable)
    5.7
    No statistical analyses for this end point

    Secondary: Intra-assay coefficient of variation. right kidney - input function: abdominal aorta. FOVA

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    End point title
    		 Intra-assay coefficient of variation. right kidney - input function: abdominal aorta. FOVA
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB. Intra-assay coefficients of variation were calculated for each input function for each kidney based on duplicate K1 determinations in each FOV.
    End point type
    Secondary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: percent
        number (not applicable)
    4.4
    No statistical analyses for this end point

    Secondary: Intra-assay coefficient of variation. left kidney - input function: abdominal aorta. FOVA

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    End point title
    		 Intra-assay coefficient of variation. left kidney - input function: abdominal aorta. FOVA
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB. Intra-assay coefficients of variation were calculated for each input function for each kidney based on duplicate K1 determinations in each FOV.
    End point type
    Secondary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: percent
        number (not applicable)
    4.3
    No statistical analyses for this end point

    Secondary: Intra-assay coefficient of variation. right kidney - input function: abdominal aorta. FOVB

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    End point title
    		 Intra-assay coefficient of variation. right kidney - input function: abdominal aorta. FOVB
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB. Intra-assay coefficients of variation were calculated for each input function for each kidney based on duplicate K1 determinations in each FOV.
    End point type
    Secondary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: percent
        number (not applicable)
    4.4
    No statistical analyses for this end point

    Secondary: Intra-assay coefficient of variation. left kidney - input function: abdominal aorta. FOVB

    		 Close Top of page
    End point title
    		 Intra-assay coefficient of variation. left kidney - input function: abdominal aorta. FOVB
    End point description
    K1 is determined for each kidney using different input functions in the 1-tissue compartment model (the left ventricular blood pool and the abdominal aorta). AA is used as input function in two different fields of view (FOVs). FOVA and FOVB. Intra-assay coefficients of variation were calculated for each input function for each kidney based on duplicate K1 determinations in each FOV.
    End point type
    Secondary
    End point timeframe
    At the end of the trial when all subjects have completed the day of examination
    End point values
    		 Two bed positions
    Number of subjects analysed
    18
    Units: Percent
        number (not applicable)
    4.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For each participant: From the first injection of Rb-82 till 48 hours after the last injection.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Two bed positions
    Reporting group description
    		 -

    Serious adverse events
    		 Two bed positions
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Two bed positions
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 18 (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: No adverse events were registered

    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
    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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