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    Clinical Trial Results:
    18F-FDG-WBC-PET/CT for PJI and after uneventful prosthesis surgery

    Summary
    EudraCT number
    		 2013-001607-36
    Trial protocol
    		 SE  
    Global end of trial date
    07 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2021
    First version publication date
    15 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Region Stockholm
    Sponsor organisation address
    Lindhagensgatan 98, Stockholm, Sweden,
    Public contact
    Annette Fransson-Andreo, verksamhetschef, Region Stockholm, annette.fransson-andreo-hernandez@sll.se
    Scientific contact
    Rimma Axelsson, professor, Region Stockholm, rimma.axelsson@sll.se
    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
    07 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluate the accuracy, sensitivity and specificity of 18F-FDG-WBC-PET/CT combined with Tc99m-Nanocolloid scintigraphy for the diagnosis of PJI as well as evaluate the uptake of 18F-FDG-WBC-PET/CT after uneventful prosthesis surgery.
    Protection of trial subjects
    Monitoring of HR, BT and RF before and after examination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2013
    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
    Sweden: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    7
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with suspected PJI in the suitable age range were asked for inclusion in the infection part of the study. Random patients with previous hip surgery were asked for inclusion in the uneventful part of the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Investigator, Data analyst [2]
    Blinding implementation details
    Blinding was only used for the evaluation of the images, the participants were not blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infection arm
    Arm description
    		 All patients with suspected PJI included in the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    18F-FDG-WBC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Autologous leukocytes were separated from the patients blood, radiolabelled with 18F-FDG and reinjected if the activity was below 600 MBq.

    Arm title
    		 Uneventful arm
    Arm description
    		 All patients without suspicion of infection
    Arm type
    		 Experimental

    Investigational medicinal product name
    18F-FDG-WBC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Autologous leukocytes were separated from the patients blood, radiolabelled with 18F-FDG and reinjected if the activity was below 600 MBq.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: The trial is not a drug trial but an evaluation of the images obtained using the radiopharmaceutical. Only the analyst of the images were blinded.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The trial is not a drug trial but an evaluation of the images obtained using the radiopharmaceutical. Only the analyst of the images were blinded.
    Number of subjects in period 1
    		Infection arm Uneventful arm
    Started
    20
    8
    Completed
    19
    8
    Not completed
    1
    0
         Death during follow-up, unrelated
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infection arm
    Reporting group description
    		 All patients with suspected PJI included in the study

    Reporting group title
    Uneventful arm
    Reporting group description
    		 All patients without suspicion of infection

    Reporting group values
    		 Infection arm Uneventful arm Total
    Number of subjects
    		 20 8 28
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 7 0 7
        From 65-84 years
    		 13 8 21
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 4 11
        Male
    		 13 4 17

    End points

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    End points reporting groups
    Reporting group title
    Infection arm
    Reporting group description
    		 All patients with suspected PJI included in the study

    Reporting group title
    Uneventful arm
    Reporting group description
    		 All patients without suspicion of infection

    Primary: Specificity

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    End point title
    		 Specificity [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    At 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: All patients in the arm underwent both examination types. McNemar's test was used to compare them. It is not possible to enter this data on the site.
    [2] - 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: Only the infection arm is used for this endpoint.
    End point values
    		 Infection arm
    Number of subjects analysed
    19
    Units: 0-100
    19
    No statistical analyses for this end point

    Primary: Uptake

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    End point title
    		 Uptake [3] [4]
    End point description
    Visual evaluation of the distribution of uptake surrounding the prosthesis
    End point type
    Primary
    End point timeframe
    At 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: Only the uneventful arm is used for this end point.
    [4] - 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: The comparison is between subjects in the arm at different time points to show correlation between time and uptake. It is not possible to enter this data on the site.
    End point values
    		 Uneventful arm
    Number of subjects analysed
    8 [5]
    Units: visual evaluation
        number (not applicable)
    8
    Notes
    [5] - Repeated measurements in some cases
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The hours surrounding the examination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Infection arm
    Reporting group description
    		 All patients with suspected PJI included in the study

    Reporting group title
    Uneventful arm
    Reporting group description
    		 All patients without suspicion of infection

    Serious adverse events
    		 Infection arm Uneventful arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infection arm Uneventful arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 20 (30.00%)
    6 / 8 (75.00%)
    Vascular disorders
    Increased blood pressure
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 8 (62.50%)
         occurrences all number
    1
    5
    Cardiac disorders
    Increased heart rate
         subjects affected / exposed
    4 / 20 (20.00%)
    3 / 8 (37.50%)
         occurrences all number
    4
    3
    Respiratory, thoracic and mediastinal disorders
    Increased respiratory rate
         subjects affected / exposed
    4 / 20 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2015
    The Infection arm changed from two independent arms to examining the first 20 patients with both examinations.
    10 Aug 2017
    The last patients in the uneventful arm changed from being examined at 3, 6 and 12 months to being examined at 24 months after the operation.

    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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