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    Clinical Trial Results:
    16α-18F-fluor-17β-estradiol PET/CT for detection of estrogen receptor positive liver metastases in breast cancer

    Summary
    EudraCT number
    		 2019-002665-35
    Trial protocol
    		 DK  
    Global end of trial date
    04 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Nov 2024
    First version publication date
    02 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    190619
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04150731
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospytal
    Sponsor organisation address
    Palle Juul Jensens Boulevard 99, Aarhus, Denmark, 8200
    Public contact
    Mette Abildgaard Pedersen, Aarhus University Hospital, +45 31411180, meabpe@biomed.au.dk
    Scientific contact
    Mette Abildgaard Pedersen, Aarhus University Hospital, +45 31411180, meabpe@biomed.au.dk
    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
    04 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate parametric and conventional FES-PET/CT as methods of quantification of estrogen receptor (ER) expression in patients with disseminated BC
    Protection of trial subjects
    GCP trail unit Aarhus University
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    6
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 At oncology department , Aarhus University Hospital

    Pre-assignment
    Screening details
    		 Inclusion criteria: metastatic ER+, human epidermal growth factor receptor 2 negative (HER2-) BC (2) at least two liver metastases visualized on CT (3) treatment with aromatase inhibitors or chemotherapy (4) postmenopausal status.

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

    Arms
    Arm title
    		 FES SCAN
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    18F-Fluoroestradiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    200 MBq

    Number of subjects in period 1
    		FES SCAN
    Started
    8
    Completed
    8

    Baseline characteristics

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

    Reporting group values
    		 Overall trail Total
    Number of subjects
    		 8 8
    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)
    		 6 6
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (41 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    FES uptake
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Tumor to background FES uptake was increased with dynamic imaging compared to static imaging.

    Subject analysis set title
    FES Uptake Patlak
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FES Uptake Patlak

    Subject analysis sets values
    		 FES uptake FES Uptake Patlak
    Number of subjects
    8
    8
    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)
    6
        From 65-84 years
    2
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    57 (41 to 74)
    Gender categorical
    Units: Subjects
        Female
    8
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    FES SCAN
    Reporting group description
    		 -

    Subject analysis set title
    FES uptake
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Tumor to background FES uptake was increased with dynamic imaging compared to static imaging.

    Subject analysis set title
    FES Uptake Patlak
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FES Uptake Patlak

    Primary: FES tumor to background

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    End point title
    		 FES tumor to background
    End point description
    Tumor to background FES uptake was increased with dynamic imaging compared to static imaging.
    End point type
    Primary
    End point timeframe
    2023
    End point values
    		 FES uptake FES Uptake Patlak
    Number of subjects analysed
    8
    8
    Units: ratio
        arithmetic mean (standard deviation)
    2.45 ( 0.2 )
    0 ( 0 )
    Statistical analysis title
    		 t-test
    Comparison groups
    FES uptake v FES Uptake Patlak
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - t-test

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 adverse event with back pain
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    FES exposure
    Reporting group description
    		 -

    Serious adverse events
    		 FES exposure
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (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
    		 FES exposure
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    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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