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    Clinical Trial Results:
    Prospective study of 18F-RGD PET-CT in assessment of response to antiangiogenic treatment in patients with renal cancer and comparison with perfusion CT

    Summary
    EudraCT number
    		 2011-002833-20
    Trial protocol
    		 GB  
    Global end of trial date
    03 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2016
    First version publication date
    12 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EP-TSC-663
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01492192
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oxford University Hospitals NHS Foundation Trust
    Sponsor organisation address
    Churchill Hospital, Oxford, United Kingdom, OX37LJ
    Public contact
    Trial Administration Team, The Early Phase Research Hub, Dept Oncology, 44 1865235312, earlyphasehub@oncology.ox.ac.uk
    Scientific contact
    Trial Administration Team, The Early Phase Research Hub, Dept Oncology, 44 1865235312, earlyphasehub@oncology.ox.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
    22 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate whether changes of uptake on 18F-RGD PET-CT before, during and after anti-angiogenic therapy are associated with tumour response in patients with cancer.
    Protection of trial subjects
    Since the adverse event profile of Fluciclatide (18F) Injection has not yet been fully established in humans, safety was monitored closely in this study given the small risk of anaphylaxis. Patients were observed for an hour following 18F injection for: Physical examination; blood pressure and pulse.
    Background therapy
    		 Patients will be given a Tyrosine Kinase Inhibitor (TKI) as per standard of care for their metastatic renal cell cancer (RCC) TKI to be given as per the current cancer network treatment protocol. The most commonly prescribed TKI for metastatic RCC is sunitinib. Other TKIs may be used for the patient to participate.. Sunitinib is typically taken orally at a dosage of 50mg once daily for 4 consecutive weeks with a 2-week rest period (that is, a complete treatment cycle of 6 weeks). Participants will be treated for 3 cycles. If significant progression is not demonstrated then patients will have continuous therapy (with restaging every 3 cycles) of sunitinib until significant progression or death.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    03 Aug 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited between 08May 2013 and 30Sept2015 from a single site in the UK.

    Pre-assignment
    Screening details
    		 22 patients were screened and twelve declined.

    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
    		 Overall trial
    Arm description
    		 All trial subjects
    Arm type
    		 Experimental

    Investigational medicinal product name
    18F Fluciclatide
    Investigational medicinal product code
    AH111585
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Given as a single bolus dose given over 20 seconds, on three occasions for three separate PET scans. Total dose 20 μg microgram(s)

    Number of subjects in period 1
    		Overall trial
    Started
    10
    Completed
    10

    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
    		 10 10
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 7 7
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 9 9

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All trial subjects

    Primary: Correlation between tumour response to TKI therapy and change in SUVmax from baseline

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    End point title
    		 Correlation between tumour response to TKI therapy and change in SUVmax from baseline [1]
    End point description
    The null hypothesis assumed no correlation between change in SUVmax and tumour response; H0: r=0; where r=Pearson’s correlation coefficient. To assess the primary endpoint of study volume and SUVpeak measurements of the tumour deposits were used. SUVpeak was chosen over SUVmax as it is more accurate. Volume of the lesions was calculated as: Volume=4/3πxyz (where x,y and z are the dimensions of tumour deposits in orthogonal planes). Change in volume and SUVpeak between scans were determined percentages. The percentage change for each patient was calculated as an average of the target and non-target lesions. Percentage changes were correlated using a Pearson’s correlation. SUVpeak change between baseline and 2nd PET-CT scan had a significant correlation with change in volume between the baseline and both the 2nd and 3rd PET-CT scans (R=0.66 P=0.04 and R=0.67, P=0.03, respectively) No correlation demonstrated between change in SUVpeak at baseline and 3rd PET-CT scans and volume changes.
    End point type
    Primary
    End point timeframe
    Changes in tumour uptake (% change in SUVmax) of 18F between baseline scan and second scan after 4 weeks TKI treatment.
    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 study with no comparator hence statistical analysis cannot be completed
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: Tumour volume in mm
        number (not applicable)
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety reporting period was for 24 hours from time of administration of the fluciclatide tracer for each 18F PET-CT scan.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Pain on cough
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 10 (10.00%)
         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
    29 Sep 2014
    Substantial amendment SA01 to update the Investigator Brochure used for Reference Safety Information

    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.
    The trial failed to recruit the 40-50 patients required to achieve statistical significance and hence is significantly under powered.
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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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