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    Clinical Trial Results:
    Androgen receptor and estrogen receptor imaging in metastatic breast cancer patients (FDHT FESPET / ARER)

    Summary
    EudraCT number
    		 2012-003981-42
    Trial protocol
    		 NL  
    Global end of trial date
    10 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2022
    First version publication date
    14 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2012.2708
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01988324
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Groningen
    Sponsor organisation address
    Hanzeplein 1, Groningen, Netherlands,
    Public contact
    Department of Medical Oncology, University Medical Center Groningen, +31 503616161, g.a.p.hospers@umcg.nl
    Scientific contact
    Department of Medical Oncology, University Medical Center Groningen, +31 503616161, g.a.p.hospers@umcg.nl
    Sponsor organisation name
    VUMC
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands,
    Public contact
    Department of Medical Oncology, VUMC, +31 204444444, e.boven@vumc.nl
    Scientific contact
    Department of Medical Oncology, VUMC, +31 204444444, e.boven@vumc.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
    01 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To visualize and quantify androgen receptor and estrogen receptor expression by PET imaging with the tracers 18F-FDHT and 18F-FES respectively.
    Protection of trial subjects
    Other than infrequent transient intravenous site discomfort, no adverse events have been noted in current published - FES PET and FDHT PET studies. Radiation exposure by the two PET imaging studies is 11.0 mSv. According to the investigators this radiation burden is justifiable, in this patient group with metastatic disease, by the information that can be obtained in this study. Tumor biopsy will be performed from an easy accessible lesion, and location will be determined based on safety aspects. The risk for significant complications and mortality from tumor biopsy is low: 0.24-1.6% and 0.11-0.48% for major complications and mortality respectively. The combined imaging techniques may show lesions that were previously unknown or may show changes in ER-expression. When biopsy confirms the presence of the metastasis and/ or confirms altered ER-expression, this may have therapeutic consequences (e.g. radiotherapy, bisphosphonates for previously unknown bone metastases, or altered systemic therapy). Therefore information obtained during this study may have beneficial effects for the patient.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2014
    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: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    9
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 21 patients were included between September 2014 and August 2015 13 were evaluable for the primary endpoint

    Pre-assignment
    Screening details
    		 21 patients were included between September 2014 and August 2015 13 were evaluable for the primary endpoint

    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
    		 Hormone receptor imaging
    Arm description
    		 Hormone receptor imagng
    Arm type
    		 Experimental

    Investigational medicinal product name
    16-alpha-[18F]fluoro-17-beta-estradiol
    Investigational medicinal product code
    18F-FES
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    222 MBq per day

    Number of subjects in period 1
    		Hormone receptor imaging
    Started
    13
    Completed
    13

    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
    		 13 13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 9 9
        From 65-84 years
    		 4 4
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Hormone receptor imaging
    Reporting group description
    		 Hormone receptor imagng

    Primary: The concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy will be evaluated.

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    End point title
    		 The concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy will be evaluated. [1]
    End point description
    FDHT PET and FES PET will be qualitatively assessed. The nuclear medicine physician visually indentifies lesions with increased tracer uptake, above background signal, which cannot be attributed to an artefact or physiological uptake. Next, 18F-FDHT, and l8F-FES-uptake will be quantified for all individual tumor lesions observed according to the European Association of Nuclear Medicine (EANM) guidelines and recorded as standardized uptake value. CT-scan and bone scan will be used to identify metastases >10 mm that were not detected on PET. The uptake of these lesions will also be quantified. The sensitivity and specificity of qualitatively scored FDHT PET will be calculated using immunohistochemistry of a biopsied lesion as golden standard. Receiver operating characteristic (ROC) analysis will be used to determine the quantitative threshold (SUVmax/mean) that optimally differentiates between AR-positive and AR-negative lesions.
    End point type
    Primary
    End point timeframe
    within 2 months
    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: See enclosed publication
    End point values
    		 Hormone receptor imaging
    Number of subjects analysed
    13
    Units: SUV
    13
    No statistical analyses for this end point

    Secondary: The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.

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    End point title
    		 The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.
    End point description
    278 lesions could be used for ER imaging
    End point type
    Secondary
    End point timeframe
    within 6 weeks
    End point values
    		 Hormone receptor imaging
    Number of subjects analysed
    13
    Units: suv
    13
    No statistical analyses for this end point

    Secondary: Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.

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    End point title
    		 Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.
    End point description
    in toal 278 lesions could be used for ER analysis
    End point type
    Secondary
    End point timeframe
    within 6 weeks
    End point values
    		 Hormone receptor imaging
    Number of subjects analysed
    13
    Units: SUV
    13
    No statistical analyses for this end point

    Secondary: Inter-observer variation in FES PET and FDHT PET results in two independent observers.

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    End point title
    		 Inter-observer variation in FES PET and FDHT PET results in two independent observers.
    End point description
    in toal 278 lesions could be used for ER analysis
    End point type
    Secondary
    End point timeframe
    approximately 2 months
    End point values
    		 Hormone receptor imaging
    Number of subjects analysed
    13
    Units: SUV
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All (serious) adverse events occurring during the study or which comes to the attention of the investigator within 28 days after the study, whether considered treatment-related or not, must be reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Frequency threshold for reporting non-serious adverse events: 2%
    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: See enclosed publication

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Aug 2014
    PI change in participating center

    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.
    n.a.
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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
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