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    Clinical Trial Results:
    Diagnostic efficacy and prognostic method [18F] DOPA-PET/CT in study of neuroblastoma: comparison with 123I-MIBG scintigraphy

    Summary
    EudraCT number
    		 2012-005398-30
    Trial protocol
    		 IT  
    Global end of trial date
    31 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Aug 2024
    First version publication date
    01 Aug 2024
    Other versions
    Summary report(s)
    		 Diagnosis, Treatment Response, and Prognosis: The Role of 18F-DOPA PET/CT in Children Affected by Neuroblastoma in Comparison with 123I-mIBG Scan: The First Prospective Study

    Trial information

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    Trial identification
    Sponsor protocol code
    dopa
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    E.O. Ospedali Galliera
    Sponsor organisation address
    Mura delle Cappuccine 14, Genoa, Italy, 16128
    Public contact
    S.S. Gestione attività di ricerca e Gran Office E.O. Ospedali Galliera, S.S. Gestione attività di ricerca e Gran Office E.O. Ospedali Galliera, 0039 0105634541, arnoldo.piccardo@galliera.it
    Scientific contact
    S.S. Gestione attività di ricerca e Gran Office E.O. Ospedali Galliera, S.S. Gestione attività di ricerca e Gran Office E.O. Ospedali Galliera, 0039 0105634541, arnoldo.piccardo@galliera.it
    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
    28 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    check the diagnostic accuracy of 18F-DOPA-PET/TC compared with scintigraphy with 123I-MIBG during the staging of disease in patients with NB
    Protection of trial subjects
    A median clinical and follow-up of 29.3 mo (range, 19–53 mo) was available for each patient.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2013
    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
    Italy: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    18
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 neuroblastoma ( NB) patients

    Pre-assignment
    Screening details
    		 -age > 12 months <18 years - patients affected by NB at onset with a high probability of returning to stage 3 and 4 of the disease based on ultrasound or CT images. Stage 2 with N-MYC amplification - histological diagnosis of NB may also be included - no previous lines of chemotherapy with the exception of steroid treatment -informed consent

    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
    		 Neuroblastoma patients
    Arm description
    		 16 high-risk and 2 intermediate-risk patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    6-[18F]fluoro-L-dopa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    (4 MBq/Kg) never < 80 MBq

    Number of subjects in period 1
    		Neuroblastoma patients
    Started
    18
    Completed
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Neuroblastoma patients
    Reporting group description
    		 16 high-risk and 2 intermediate-risk patients

    Reporting group values
    		 Neuroblastoma patients Total
    Number of subjects
    		 18 18
    Age categorical
    children 2- 11 years
    Units: Subjects
        children ( 2 - 11 years)
    		 18 18
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 12 12
    Subject analysis sets

    Subject analysis set title
    Neuroblastoma NB patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary aim of this study was to evaluate the diagnosticrole of 18F-DOPA PET/CT at the time of first diagnosis in childrenwith neuroblastoma.

    Subject analysis sets values
    		 Neuroblastoma NB patients
    Number of subjects
    18
    Age categorical
    children 2- 11 years
    Units: Subjects
        children ( 2 - 11 years)
    18
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    12
        Male
    6

    End points

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    End points reporting groups
    Reporting group title
    Neuroblastoma patients
    Reporting group description
    		 16 high-risk and 2 intermediate-risk patients

    Subject analysis set title
    Neuroblastoma NB patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary aim of this study was to evaluate the diagnosticrole of 18F-DOPA PET/CT at the time of first diagnosis in childrenwith neuroblastoma.

    Primary: the diagnostic accuracy of 18F-DOPA-PET/CT compared to 123I-MIBG scintigraphy

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    End point title
    		 the diagnostic accuracy of 18F-DOPA-PET/CT compared to 123I-MIBG scintigraphy [1]
    End point description
    The primary aim of this study was to evaluate the diagnostic role of 18F-DOPA PET/CT at the time of first diagnosis in children with neuroblastoma. We also investigated the ability of this procedure to assess response to chemotherapy. Lastly, we evaluated the prognostic role of 18F-DOPA PET/CT in high-risk neuroblastoma patients on diagnosis and after induction chemotherapy by testing the relationship between WBMB, progression-free survival (PFS), and overall survival (OS)
    End point type
    Primary
    End point timeframe
    48 month
    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: Diagnostic accuracy was considered as the primary endpoint ratio between [true positives (VP) + true negatives (VN)] / [total of subjects (N)]. Each subject will be subjected to both reference tests ( experimental and standard ), for the calculation of the sample was used the McNemar statistical test, A power of 80% was calculated with a total (minimum) sample of 40 subjects, it is necessary to detect a difference of 30% in terms of the discordant proportions (p21 and p12 of the aforemention
    End point values
    		 Neuroblastoma patients Neuroblastoma NB patients
    Number of subjects analysed
    18 [2]
    18 [3]
    Units: MBq/kg megabecquerel(s)/kilogram
    18
    18
    Notes
    [2] - ..
    [3] - ..
    No statistical analyses for this end point

    Secondary: The impact on prognosis and clinical management will be a secondary end-point of our evaluation.

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    End point title
    		 The impact on prognosis and clinical management will be a secondary end-point of our evaluation.
    End point description
    Lastly, we evaluated the prognostic role of 18F-DOPA PET/CT in high-risk neuroblastoma patients on diagnosis and after induction chemotherapy by testing the relationship between WBMB, progression-free survival (PFS), and overall survival (OS)
    End point type
    Secondary
    End point timeframe
    48 month
    End point values
    		 Neuroblastoma patients Neuroblastoma NB patients
    Number of subjects analysed
    18
    18
    Units: MBq/kg megabecquerel(s)/kilogram
    18
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The adverse event will be notified to the Galliera Coordinating Center within 24 hours of the principal investigator becoming aware of it and subsequent relevant information will be communicated within eight days of the first report
    Adverse event reporting additional description
    no adverse event reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Frequency threshold for reporting non-serious adverse events: 0%
    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: The adverse event will be notified to the Galliera Coordinating Center within 24 hours of the principal investigator becoming aware of it and subsequent relevant information will be communicated within eight days of the first report

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2015
    - update of the protocol (statistical part ) - Closure of three satellite centers due to lack of enrollment

    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
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