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    Clinical Trial Results:
    Pilot Feasibility Study: Inflammation and presence of M2 macrophages explorations with[18F]-DPA-714 PET/CT in Triple Negative breast cancers

    Summary
    EudraCT number
    		 2019-001463-75
    Trial protocol
    		 FR  
    Global end of trial date
    21 Jul 2021

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ICO-2019-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04320030
    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
    Nadia ALLAM, Project Manager, INSTITUT DE CANCEROLOGIE DE L'OUEST, +33 2 40 67 98 26, nadia.allam@ico.unicancer.fr
    Scientific contact
    Nadia ALLAM, Project Manager, INSTITUT DE CANCEROLOGIE DE L'OUEST, +33 2 40 67 98 26, nadia.allam@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
    21 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Study of correlations between tumor immunohistochemical analysis (IHC) and in vivo [18F]-DPA-714 PET/TDM analysis for detection of M2 macrophages infiltrating breast cancer tumor Triple Negative
    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
    		 [18F]DPA-714
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    02 Dec 2019
    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: 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)
    7
    From 65 to 84 years
    5
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 1st consent signature: 10/06/2020, 1st inclusion: 11/06/2020, LVLP: 21/07/2021

    Pre-assignment
    Screening details
    		 Primary Triple Negative Breast Cancer before surgery

    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
    		 [18F]DPA-714
    Arm description
    		 [18F]DPA-714 PET-CT
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]DPA-714
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    [18F]DPA-714 is administered at a dose of 3.5 MBq/kg ± 10%, with a minimum of 150 MBq and a maximum of 400 MBq. Dynamic PET images are performed in list mode for 30 minutes. 60 min after [18F]DPA-714 injection, procubitus acquisition centred on the thorax + axillary cavities is performed for approximately 15 min.

    Number of subjects in period 1
    		[18F]DPA-714
    Started
    13
    Completed
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 [18F]DPA-714

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 13 13
    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)
    		 7 7
        From 65-84 years
    		 5 5
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    M1/M2 macrophage polarisation
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    M1/M2 macrophage polarization has been assessed by tumor immunohistochemistry analysis.

    Subject analysis set title
    Correlation Between % M2 Using CD163 and SUV Max [18F]DPA-714
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Correlation between % M2 Correlation between M1/M2 macrophages using CD68 and SUV max [18F]DPA-714 has been assessed using a Spearman correlation coefficient. If p value > 0.05, no significant correlation

    Subject analysis set title
    Correlation Between M1/M2 Macrophages With CD68 and SUV Max [1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Correlation between M1/M2 macrophages with CD68 and SUV max [18F]DPA-714 PET/CT using spearman's correlation

    Subject analysis set title
    Correlation Between TSPO Genotype (HAB, MAB and LAB) and [18F]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Tumor uptake of [18F]DPA-714 was assessed using dynamic PET/CT time-activity curves (TACs). Uptake patterns were classified relative to the contralateral pectoral muscle (reference tissue) into three predefined categories: above, equal to, or below muscular background. These categories were compared across TSPO genotypes (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) determined from blood samples.

    Subject analysis sets values
    		 M1/M2 macrophage polarisation Correlation Between % M2 Using CD163 and SUV Max [18F]DPA-714 Correlation Between M1/M2 Macrophages With CD68 and SUV Max [1 Correlation Between TSPO Genotype (HAB, MAB and LAB) and [18F]
    Number of subjects
    13
    13
    13
    13
    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)
    7
        From 65-84 years
    5
        85 years and over
    1
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    13
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    [18F]DPA-714
    Reporting group description
    		 [18F]DPA-714 PET-CT

    Subject analysis set title
    M1/M2 macrophage polarisation
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    M1/M2 macrophage polarization has been assessed by tumor immunohistochemistry analysis.

    Subject analysis set title
    Correlation Between % M2 Using CD163 and SUV Max [18F]DPA-714
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Correlation between % M2 Correlation between M1/M2 macrophages using CD68 and SUV max [18F]DPA-714 has been assessed using a Spearman correlation coefficient. If p value > 0.05, no significant correlation

    Subject analysis set title
    Correlation Between M1/M2 Macrophages With CD68 and SUV Max [1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Correlation between M1/M2 macrophages with CD68 and SUV max [18F]DPA-714 PET/CT using spearman's correlation

    Subject analysis set title
    Correlation Between TSPO Genotype (HAB, MAB and LAB) and [18F]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Tumor uptake of [18F]DPA-714 was assessed using dynamic PET/CT time-activity curves (TACs). Uptake patterns were classified relative to the contralateral pectoral muscle (reference tissue) into three predefined categories: above, equal to, or below muscular background. These categories were compared across TSPO genotypes (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) determined from blood samples.

    Primary: M1/M2 Macrophage Polarization

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    End point title
    		 M1/M2 Macrophage Polarization [1]
    End point description
    M1/M2 macrophage polarization has been assessed by tumor immunohistochemistry analysis.
    End point type
    Primary
    End point timeframe
    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: This endpoint is descriptive and no formal statistical comparison is planned due to the single-arm design.
    End point values
    		 [18F]DPA-714
    Number of subjects analysed
    13
    Units: participants
        Preponderance of M2-polarised macrophages
    11
        Non preponderance of M2-polarised macrophages
    2
    No statistical analyses for this end point

    Primary: Correlation Between % M2 Using CD163 and SUV Max [18F]DPA-714 PET/CT

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    End point title
    		 Correlation Between % M2 Using CD163 and SUV Max [18F]DPA-714 PET/CT [2]
    End point description
    Correlation between % M2 Correlation between M1/M2 macrophages using CD68 and SUV max [18F]DPA-714 has been assessed using a Spearman correlation coefficient. If p value > 0.05, no significant correlation
    End point type
    Primary
    End point timeframe
    2 months
    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: This endpoint is descriptive and no formal statistical comparison is planned due to the single-arm design.
    End point values
    		 [18F]DPA-714 Correlation Between % M2 Using CD163 and SUV Max [18F]DPA-714
    Number of subjects analysed
    13
    13
    Units: Spearman's rho
    number (not applicable)
        Spearman's rho
    -0.45
    -0.45
        p value
    0.12
    0.12
    No statistical analyses for this end point

    Primary: Correlation Between M1/M2 Macrophages With CD68 and SUV Max [18F]DPA-714 PET/CT

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    End point title
    		 Correlation Between M1/M2 Macrophages With CD68 and SUV Max [18F]DPA-714 PET/CT [3]
    End point description
    Correlation between M1/M2 macrophages with CD68 and SUV max [18F]DPA-714 PET/CT using spearman's correlation
    End point type
    Primary
    End point timeframe
    2 months
    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: This endpoint is descriptive and no formal statistical comparison is planned due to the single-arm design.
    End point values
    		 [18F]DPA-714
    Number of subjects analysed
    13
    Units: Spearman's rho
    number (not applicable)
        Spearman's rho
    -0.30
        p value
    0.31
    No statistical analyses for this end point

    Secondary: Correlation Between TSPO Genotype (HAB, MAB and LAB) and [18F]DPA-714 PET/CT Tumor Uptake

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    End point title
    		 Correlation Between TSPO Genotype (HAB, MAB and LAB) and [18F]DPA-714 PET/CT Tumor Uptake
    End point description
    Tumor uptake of [18F]DPA-714 was assessed using dynamic PET/CT time-activity curves (TACs). Uptake patterns were classified relative to the contralateral pectoral muscle (reference tissue) into three predefined categories: above, equal to, or below muscular background. These categories were compared across TSPO genotypes (HAB, MAB, LAB) determined from blood samples.
    End point type
    Secondary
    End point timeframe
    2 months
    End point values
    		 [18F]DPA-714
    Number of subjects analysed
    13
    Units: participants
        HAB - Above muscular background
    2
        HAB - Equal to muscular background
    3
        HAB - Below muscular background
    0
        MAB - Above muscular background
    2
        MAB - Equal to muscular background
    3
        MAB - Below muscular background
    1
        LAB - Above muscular background
    0
        LAB - Equal to muscular background
    1
        LAB - Below muscular background
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse Events reporting: from consent signature to 28 days after [18F]DPA-714 administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    3
    Reporting groups
    Reporting group title
    [18F]DPA-714
    Reporting group description
    		 -

    Serious adverse events
    		 [18F]DPA-714
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 [18F]DPA-714
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 13 (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
    01 Jul 2020
    Clarify the [18F]DPA-714 PET/CT procedure, the MRI procedure and an exclusion criterion. Modification of SAEs declaration procedure. Modification of informed consent: add signature of consent for genotyping of the TSPO translocator protein in blood
    21 Sep 2020
    Declaration of a new [18F]DPA-714 production 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.
    No

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38913962
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