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    Clinical Trial Results:
    68Ga-PSMA-PET/CT imaging for locally advanced, recurrent and metastatic adenoid cystic carcinoma or salivary duct carcinoma

    Summary
    EudraCT number
    		 2017-002093-40
    Trial protocol
    		 NL  
    Global end of trial date
    14 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2022
    First version publication date
    24 Jun 2022
    Other versions
    Summary report(s)
    		 full_paper

    Trial information

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    Trial identification
    Sponsor protocol code
    104902
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03319641
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 NL61699.091.17: CCMO dossier code
    Sponsors
    Sponsor organisation name
    Radboud university medical center
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    Carla M.L. van Herpen, Radboudumc, +31 0243667251, carla.vanherpen@radboudumc.nl
    Scientific contact
    Carla M.L. van Herpen, Radboudumc, +31 0243667251, carla.vanherpen@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
    Final
    Date of interim/final analysis
    14 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans
    Protection of trial subjects
    68Ga-PSMA-PET/CT imaging is a imaging modality which is well known and often used in patients with recurrent prostate cancer. In these patients, no serious side effect have been reported. There is no reason to expect otherwise in our study population of patients with incurable ACC or SDC. In case unexpected side-effect do occur, the facilities to deliver emergency medical support are available at the study center. Therefore, we conclude that the risk of injury is small and if an injury occurs, it will be minor, which means the risk classification is negligible according to the NFU-risk classification.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2017
    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: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    15
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Source population: - Patients with locally advanced, recurrent or metastatic ACC/SDC who are treated at the Department of Medical Oncology of the Radboudumc. - Patients with locally advanced, recurrent or metastatic ACC/SDC who heard or read about this study and contact the investigators to ask whether they can take part in the study.

    Pre-assignment
    Screening details
    		 In order to be eligible to participate in this study, a subject must meet all of the following criteria: - locally advanced, recurrent or metastatic ACC/SDC - Age ≥ 18 years old - Ability to provide written informed consent

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

    Arms
    Arm title
    		 single arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-PSMA-HBED-CC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2MBq/kg body weight

    Number of subjects in period 1
    		single arm
    Started
    25
    Completed
    25

    Baseline characteristics

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

    Reporting group values
    		 trial Total
    Number of subjects
    		 25 25
    Age categorical
    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)
    		 15 15
        From 65-84 years
    		 10 10
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    single arm
    Reporting group description
    		 -

    Subject analysis set title
    final analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    final analysis

    Primary: tumor/liver-ratio >1

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    End point title
    		 tumor/liver-ratio >1
    End point description
    the percentage of patients with a tumor/liver-ratio >1
    End point type
    Primary
    End point timeframe
    n.a.
    End point values
    		 single arm final analysis
    Number of subjects analysed
    25
    25
    Units: ratio
        number (not applicable)
    25
    25
    Statistical analysis title
    		 tumor/liver ratio
    Comparison groups
    single arm v final analysis
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 5 [2]
    Method
    		 n.a., see comment
    Parameter type
    		 n.a.
    Confidence interval
    Notes
    [1] - a ratio was described without statistical testing because of the low number of patients
    [2] - the primairy outcome was not statistically tested. this was a hypothesis generating study without formal testing

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    whole trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    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: 68Ga-PSMA-PET/CT imaging is a imaging modality which is well known and often used in patients with recurrent prostate cancer. In these patients, no serious side effect have been reported. There is no reason to expect otherwise in our study population of patients with incurable ACC or SDC. In case unexpected side-effect do occur, the facilities to deliver emergency medical support are available at the study center. In this study, no adverse events were recorded.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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