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    Clinical Trial Results:
    Imaging of tumour microenvironment in patients with oropharyngeal head and neck squamous cell carcinoma using RGD PET/CT imaging.

    Summary
    EudraCT number
    		 2019-001843-37
    Trial protocol
    		 NL  
    Global end of trial date
    01 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jun 2025
    First version publication date
    05 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    52649
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboud University Medical Center
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands, 6525 GA
    Public contact
    Department Nuclear Medicine, Radboud University Medical Center, +31 243613651, evelein.vangenugten@radboudumc.nl
    Scientific contact
    Department Nuclear Medicine, Radboud University Medical Center, +31 243613651, evelein.vangenugten@radboudumc.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
    Interim
    Date of interim/final analysis
    01 May 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the differences in [68Ga]Ga-RGD2 uptake and CT perfusion parameters between HPV+ HNSCC tumours and HPV- HNSCC tumours in patients who will be treated with chemoradiotherapy. Furthermore, the changes in [68Ga]Ga-RGD2 uptake and CT perfusion parameters in tumours before and during chemoradiotherapy will be investigated.
    Protection of trial subjects
    To minimize hospital visits, scans were planned on days of already existing hospital visits needed for standard of care - where possible.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2019
    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: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    4
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients that met the inclusion criteria were asked to participate in the trial, and availability of logistics of study visists was checked. If these criteria were met, the patient could participate.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 9
    Number of subjects completed
    		 9

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HPV negative
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ga RGD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    bolus of 200 MBQ plusminus 10%

    Arm title
    		 HPV positive
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ga RGD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    bolus of 200 MBQ plusminus 10%

    Number of subjects in period 1
    		HPV negative HPV positive
    Started
    4
    5
    Completed
    4
    5

    Baseline characteristics

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

    Reporting group title
    HPV positive
    Reporting group description
    		 -

    Reporting group values
    		 HPV negative HPV positive Total
    Number of subjects
    		 4 5 9
    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
        arithmetic mean (full range (min-max))
    		 66.8 (62 to 72) 61.6 (49 to 71) -
    Gender categorical
    Units: Subjects
        Female
    		 1 0 1
        Male
    		 3 5 8
    Subject analysis sets

    Subject analysis set title
    HPV positive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    It is proven that besides more broad carcinogenesis patterns, oropharyngeal carcinomas can develop due to the lingering humane papilloma virus in the throat. This subtype of patients have higher survival rate, but is it still unknown what the exact mechanism is behind these differences in survival. Therefore we aim to compare patients where HPV presence is proven on the tumor tissue with patients where this virus was not detected.

    Subject analysis set title
    HPV negative
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    It is proven that besides more broad carcinogenesis patterns, oropharyngeal carcinomas can develop due to the lingering humane papilloma virus in the throat. This subtype of patients have higher survival rate, but is it still unknown what the exact mechanism is behind these differences in survival. Therefore we aim to compare patients where HPV presence is proven on the tumor tissue with patients where this virus was not detected.

    Subject analysis sets values
    		 HPV positive HPV negative
    Number of subjects
    5
    4
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    61.6 (49 to 71)
    66.8 (62 to 72)
    Gender categorical
    Units: Subjects
        Female
    1
    0
        Male
    3
    5

    End points

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    End points reporting groups
    Reporting group title
    HPV negative
    Reporting group description
    		 -

    Reporting group title
    HPV positive
    Reporting group description
    		 -

    Subject analysis set title
    HPV positive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    It is proven that besides more broad carcinogenesis patterns, oropharyngeal carcinomas can develop due to the lingering humane papilloma virus in the throat. This subtype of patients have higher survival rate, but is it still unknown what the exact mechanism is behind these differences in survival. Therefore we aim to compare patients where HPV presence is proven on the tumor tissue with patients where this virus was not detected.

    Subject analysis set title
    HPV negative
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    It is proven that besides more broad carcinogenesis patterns, oropharyngeal carcinomas can develop due to the lingering humane papilloma virus in the throat. This subtype of patients have higher survival rate, but is it still unknown what the exact mechanism is behind these differences in survival. Therefore we aim to compare patients where HPV presence is proven on the tumor tissue with patients where this virus was not detected.

    Primary: Uptake of 68Ga-RGD2 in tumor lesions

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    End point title
    		 Uptake of 68Ga-RGD2 in tumor lesions [1]
    End point description
    End point type
    Primary
    End point timeframe
    Measured on the 68Ga-RGD2 PET/CT made pre-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: For interim analysis we used arithmetic mean and standard deviation. Statistics will be used in the paper to be published
    End point values
    		 HPV positive HPV negative
    Number of subjects analysed
    Units: SUV
        arithmetic mean (full range (min-max))
    6.1 (4.9 to 8.7)
    7.7 (5.4 to 9.9)
    No statistical analyses for this end point

    Primary: CT perfusion paramters

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    End point title
    		 CT perfusion paramters [2]
    End point description
    End point type
    Primary
    End point timeframe
    Measured on the CT perfusion scan made pre-treatment
    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: For interim analysis we used arithmetic mean and standard deviation. Statistics will be used in the paper to be published
    End point values
    		 HPV positive HPV negative
    Number of subjects analysed
    Units: perfusion
        arithmetic mean (standard deviation)
    11249 ( 1578 )
    13016 ( 1807 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    within the time frame of patient participation
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC
    Dictionary version
    5.0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: There are no (S)AEs as it is a diagnostic IMP

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Oct 2020
    Reduction of number of scans to speed up inclusion

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Mar 2020
    COVID-19 global pandemic
    08 Jun 2020

    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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