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    Clinical Trial Results:
    Prospective phase II pilot study, assessing imaging performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in metastatic triple negative breast cancer patients OPALESCENCE: zircon PET-CT imaging TLX metastatic triple Negative Cancer

    Summary
    EudraCT number
    		 2020-003805-71
    Trial protocol
    		 FR  
    Global end of trial date
    13 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2026
    First version publication date
    08 Jul 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ICO-2020-25
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04758780
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    INSTITUT DE CANCEROLOGIE DE L'OUEST
    Sponsor organisation address
    Boulevard Jacques Monod, SAINT HERBLAIN, France, 44800
    Public contact
    Clinical Research Dept- Promotion R, INSTITUT DE CANCEROLOGIE DE L'OUEST, +33 240679900, promotionrc@ico.unicancer.fr
    Scientific contact
    Clinical Research Dept- Promotion R, INSTITUT DE CANCEROLOGIE DE L'OUEST, +33 2406799000, promotionrc@ico.unicancer.fr
    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
    13 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT versus a conventional 18FDG PET/CT scan where comparison will be made on a per lesion analysis basis
    Protection of trial subjects
    In order to ensure the protection of the rights, safety and well-being of trial subjects, this clinical trial was performed in compliance with the principles laid down in the declaration of Helsinki, good Clinical Practice and European regulation.
    Background therapy
    		 -
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Feb 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    5
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient signed the informed consent and was included on 21 SEP 2021. The last patient was included on 17 MAY 2023

    Pre-assignment
    Screening details
    		 Patient with metatstatic Triple Negative Breast Cancer (TNBC). 12 patients have been screened and included in the trial.

    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
    		 89Zr- Girentuximab (89Zr-TLX250)
    Arm description
    		 89Zr-TLX250 is administred on day 0. a whole body PET/CT scan is perormed on day 5 (+/-2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    89Zr-TLX250
    Investigational medicinal product code
    Other name
    89Zr- Girentuxima
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    The mass dose of 89Zr-TLX250 to be used in this study will be 10 mg, labelled with 37 MBq (±10%) 89Zr per dose. Each patient will receive a single slow intravenous (IV) administration over a minimum of 3 minutes on Day 0 (after pre-dose assessments), at the nuclear medicine service of the respective study site. On D5 (± 2) days post administration of 89Zr-TLX250, a whole body PET/CT scan will be acquired from skull to mid-thigh using 6-8 bed positions with 10 minute acquisition time per bed position.

    Number of subjects in period 1
    		89Zr- Girentuximab (89Zr-TLX250)
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 12 12
    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)
    		 5 5
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    89Zr- Girentuximab (89Zr-TLX250)
    Reporting group description
    		 89Zr-TLX250 is administred on day 0. a whole body PET/CT scan is perormed on day 5 (+/-2).

    Primary: Number of total lesions

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    End point title
    		 Number of total lesions [1]
    End point description
    The number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT is reported to assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT and 18FDG) PET/CT during the study period.
    End point type
    Primary
    End point timeframe
    5 days after 89Zr-TLX250 administration
    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: No inferential statistical analysis was planned for this endpoint. The results are presented descriptively as a comparison of the number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT
    End point values
    		 89Zr- Girentuximab (89Zr-TLX250)
    Number of subjects analysed
    12
    Units: lesions
        89Zr-TLX250 PET/CT
    264
        18FDG PET/CT
    231
    No statistical analyses for this end point

    Primary: Number of brain lesions

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    End point title
    		 Number of brain lesions [2]
    End point description
    Number of brain lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and 18FDG PET/CT. The detection performance of 89Zr-TLX250 PET/CT and 18FDG PET/CT for identifying brain lesions has been compared.
    End point type
    Primary
    End point timeframe
    5 days after 89Zr-TLX250 administration
    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: No inferential statistical analysis was planned for this endpoint. The results are presented descriptively as a comparison of the number of bone lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT
    End point values
    		 89Zr- Girentuximab (89Zr-TLX250)
    Number of subjects analysed
    12
    Units: lesions
        89Zr-TLX250 PET/CT
    3
        18FDG PET/CT
    1
    No statistical analyses for this end point

    Primary: Number of breast lesions

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    End point title
    		 Number of breast lesions [3]
    End point description
    Number of breast lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
    End point type
    Primary
    End point timeframe
    5 days aftre 89Zr-TLX250 PET/CT administration
    Notes
    [3] - 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: No inferential statistical analysis was planned for this endpoint. The results are presented descriptively as a comparison of the number of lymph nodes lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT
    End point values
    		 89Zr- Girentuximab (89Zr-TLX250)
    Number of subjects analysed
    12
    Units: lesions
        89Zr-TLX250 PET/CT
    25
        18FDG PET/CT
    23
    No statistical analyses for this end point

    Primary: Number of bone lesions

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    End point title
    		 Number of bone lesions [4]
    End point description
    Number of bone lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
    End point type
    Primary
    End point timeframe
    5 days aftre 89Zr-TLX250 PET/CT administration
    Notes
    [4] - 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: No inferential statistical analysis was planned for this endpoint. The results are presented descriptively as a comparison of the number of lung lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT
    End point values
    		 89Zr- Girentuximab (89Zr-TLX250)
    Number of subjects analysed
    12
    Units: lesions
        89Zr-TLX250 PET/CT
    102
        18FDG PET/CT
    111
    No statistical analyses for this end point

    Primary: Number of lymph nodes lesions

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    End point title
    		 Number of lymph nodes lesions [5]
    End point description
    Number of lymph nodes lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
    End point type
    Primary
    End point timeframe
    5 days aftre 89Zr-TLX250 PET/CT administration
    Notes
    [5] - 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: No inferential statistical analysis was planned for this endpoint. The results are presented descriptively as a comparison of the number of liver lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT
    End point values
    		 89Zr- Girentuximab (89Zr-TLX250)
    Number of subjects analysed
    12
    Units: lesions
        89Zr-TLX250 PET/CT
    65
        18FDG PET/CT
    74
    No statistical analyses for this end point

    Primary: Number of lung lesions

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    End point title
    		 Number of lung lesions [6]
    End point description
    Number of lung lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
    End point type
    Primary
    End point timeframe
    5 days aftre 89Zr-TLX250 PET/CT administration
    Notes
    [6] - 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: No inferential statistical analysis was planned for this endpoint. The results are presented descriptively as a comparison of the number of brain lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT
    End point values
    		 89Zr- Girentuximab (89Zr-TLX250)
    Number of subjects analysed
    12
    Units: lesions
        89Zr-TLX250 PET/CT
    17
        18FDG PET/CT
    27
    No statistical analyses for this end point

    Primary: Number of liver lesions

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    End point title
    		 Number of liver lesions [7]
    End point description
    Number of liver lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
    End point type
    Primary
    End point timeframe
    5 days aftre 89Zr-TLX250 PET/CT administration
    Notes
    [7] - 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: No inferential statistical analysis was planned for this endpoint. The results are presented descriptively as a comparison of the number of breast lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT
    End point values
    		 89Zr- Girentuximab (89Zr-TLX250)
    Number of subjects analysed
    12
    Units: lesions
        89Zr-TLX250 PET/CT
    12
        18FDG PET/CT
    19
    No statistical analyses for this end point

    Secondary: concordance between 89Zr-TLX250 PET/CT uptake and CAIX histological expression

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    End point title
    		 concordance between 89Zr-TLX250 PET/CT uptake and CAIX histological expression
    End point description
    Number of patients with a concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
    End point type
    Secondary
    End point timeframe
    5 days aftre 89Zr-TLX250 PET/CT administration
    End point values
    		 89Zr- Girentuximab (89Zr-TLX250)
    Number of subjects analysed
    12
    Units: partipants
        concordance
    7
        No concordance
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    30 days after 89Zr-TLX250 PET/CT administration
    Adverse event reporting additional description
    All Adverse Events related to 89Zr-TLX250 are reported and assessed using CTCAE v5.0 scale
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Safety of 89Zr-TLX250
    Reporting group description
    		 safety data collected 30 days after 89Zr-TLX250 administration

    Serious adverse events
    		 Safety of 89Zr-TLX250
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (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
    		 Safety of 89Zr-TLX250
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    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: No adverse events (serious or non-serious) and no deaths were reported during the study period.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2022
    Extension of the recruitment period by 18 months and amendment of an inclusion criterion. Transmission of patients safety data.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/41174094
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