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    Clinical Trial Results:
    A Pilot Study Investigating the Sensitivity of 18F-labelled Sodium Fluoride PET-CT for Detecting Skeletal Metastases in Renal Cell Carcinoma compared to Planar Bone Scintigraphy and Multidetector CT

    Summary
    EudraCT number
    		 2010-024624-20
    Trial protocol
    		 GB  
    Global end of trial date
    06 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OCRD2010/22
    Additional study identifiers
    ISRCTN number
    		 ISRCTN66828876
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Foundation Trust
    Sponsor organisation address
    Hills Road, Cambridge University Hospitals NHS Foundation Trus, United Kingdom, CB2 0QQ
    Public contact
    Prasanna Kapilan, Cambridge clinical trials unit (CCTU), +44 1223 596 474 , Prasanna.kapilan@addenbrookes.nhs.uk
    Scientific contact
    Dr Ferdia Gallagher, Cambridge University Hospitals NHS Foundation Trust, fag1000@cam.ac.uk
    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
    30 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if 18F-labelled sodium fluoride Na18FPET- CT is more sensitive at detecting bone metastases in renal cell carcinoma than conventional techniques i.e. bone scintigraphy (including SPECT of the lower bdomen/pelvis) and computed tomography (CT). Number, site, and extent of metastases will be evaluated.
    Protection of trial subjects
    "To minimise radiation, a scintigram will only be performed if it has not already been performed within 28 days in Addenbrooke's. There is a potential risk to a fetus but pregnant women will be excluded and, where appropriate, a pregnancy test will be performed. There will be up to three extra visits to hospital. Where possible, the screening visit will coincide with routine clinic visits. Patients will be reimbursed for travel. There will be no invasive procedures in this study other than injections of the imaging agents that may cause slight discomfort and bruising.Drawing blood, in the case of a pregnancy test, may cause pain, bruising, lightheadedness, and rarely, infection."
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    08 Dec 2011
    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
    United Kingdom: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    3
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Screened 15 patients and 11 patients enrolled

    Pre-assignment
    Screening details
    		 Screened 15 patients and 11 patients enrolled

    Pre-assignment period milestones
    Number of subjects started
    		 15 [1]
    Number of subjects completed
    		 11

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 not meeting inclusion criteria: 1
    Reason: Number of subjects
    		 Declined to participate: 2
    Reason: Number of subjects
    		 not specified: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 15 screened and 11 patients enrolled to receive the protocol intervention.
    Period 1
    Period 1 title
    On study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 18-F-labelled sodium fluoride
    Arm description
    		 All enrolled
    Arm type
    		 Single arm

    Investigational medicinal product name
    18F-labelled sodium fluoride
    Investigational medicinal product code
    N/A
    Other name
    N/A
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    up to 250 MBq

    Number of subjects in period 1
    		18-F-labelled sodium fluoride
    Started
    11
    Screening
    11
    Completed
    10
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    18-F-labelled sodium fluoride
    Reporting group description
    		 All enrolled

    Reporting group values
    		 18-F-labelled sodium fluoride Total
    Number of subjects
    		 11 11
    Age categorical
    all enrolled
    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)
    		 3 3
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Gender categorical
    all enrolled
    Units: Subjects
        Female
    		 7 7
        Male
    		 4 4
    ECOG status
    ECOG status
    Units: Subjects
        ECOG score 0
    		 4 4
        ECOG score 1
    		 4 4
        ECOG score 2
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    18-F-labelled sodium fluoride
    Reporting group description
    		 All enrolled

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint [1]
    End point description
    To detect and compare the number of metastases detected with Na18F-PETCT, 99mTc-MDP bone scintigraphy and multidetector CT.
    End point type
    Primary
    End point timeframe
    Either the PET-CT or the scintigram can be performed first but they must be done within 28 days of each other
    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: This is a single arm trial to assess the number of metastases detected with Na18F-PET-CT, bone scintigraphy and multidetector CT alone. Analyses performed could not be reported as it is a single arm trial. The pre-specified Wilcoxon signed rank test (paired test) was performed. The results are as follows. 18F-NaF PET-CT versus multidetector CT (n=10) , p value = 0.007 18F-NaF PET-CT versus Bone scintigraphy (n=10), p value = 0.007
    End point values
    		 18-F-labelled sodium fluoride
    Number of subjects analysed
    10
    Units: number of metastases detected
        Number of malignant lesions with bone scinitgraphy
    22
        Number of malignant lesions with multidetector CT
    35
        Number of malignant lesions with Na18F-PETCT per p
    77
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of consent to end of year 1
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    All enrolled
    Reporting group description
    		 N/A

    Serious adverse events
    		 All enrolled
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (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 enrolled
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    Musculoskeletal and connective tissue disorders
    pain
    Additional description: discomfort during the 18F-NAF PET/CT imaging
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Aug 2012
    Extend the trial duration, allow nurses to consent, amend order of scans
    29 Nov 2012
    Amend inclusion criteria

    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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