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    Clinical Trial Results:
    Non invasive imaging of [18F]HX4 with Positron-Emission-Tomography (PET) in Head and Neck Cancer.

    Summary
    EudraCT number
    		 2011-001812-80
    Trial protocol
    		 NL  
    Global end of trial date
    25 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2024
    First version publication date
    16 Feb 2024
    Other versions
    Summary report(s)
    		 Article 2015

    Trial information

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    Trial identification
    Sponsor protocol code
    11-12-23/03-intern-6470
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01347281
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Maastro
    Sponsor organisation address
    Dr. Tanslaan 12, Maastricht, Netherlands,
    Public contact
    Maastro Clinic, Maastro Clinic, 0031 0884455600, philippe.lambin@maastro.nl
    Scientific contact
    Maastro Clinic, Maastro Clinic, 0031 0884455600, philippe.lambin@maastro.nl
    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
    18 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in head and neck cancer tumors
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 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
    Netherlands: 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)
    16
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible patients with head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, larynx (T2, T3, T4, any N, M0), tumor diameter ≥ 2,5 cm, planned to be treated with curative primary radiation treatment (+/- concurrent chemotherapy) are included.

    Pre-assignment
    Screening details
    		 HNSCC

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

    Arms
    Arm title
    		 HX4 injection
    Arm description
    		 HX4
    Arm type
    		 Experimental

    Investigational medicinal product name
    HX4
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    444 MBq (12 mCi) [18F]HX4

    Number of subjects in period 1
    		HX4 injection
    Started
    20
    Completed
    20

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (standard deviation)
    		 60 ± 1 -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    HX4 injection
    Reporting group description
    		 HX4

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol

    Primary: Visualisation of tumor hypoxia with [18F] HX4 PET imaging

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    End point title
    		 Visualisation of tumor hypoxia with [18F] HX4 PET imaging [1]
    End point description
    End point type
    Primary
    End point timeframe
    After scan
    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: An article was included.
    End point values
    		 HX4 injection
    Number of subjects analysed
    20
    Units: 20
        number (not applicable)
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From inclusion untill after scanning period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Frequency threshold for reporting non-serious adverse events: 1%
    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: An article is included.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Aug 2013
    Less scans and additional analysis
    29 Nov 2013
    New suplier of HX4

    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.
    NA
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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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