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    Clinical Trial Results:
    Efficacia diagnostica della metodica 18F-DOPA-PET/TC nello studio del Neuroblastoma: confronto con scintigrafia 123I-MIBG.

    Summary
    EudraCT number
    		 2010-018456-27
    Trial protocol
    		 IT  
    Global end of trial date
    20 Feb 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Aug 2024
    First version publication date
    02 Aug 2024
    Other versions
    Summary report(s)
    		 Comparison of 18F-dopa PET/CTand 123I-MIBG scintigraphy in stage 3 and 4 neuroblastoma: a pilot study

    Trial information

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    Trial identification
    Sponsor protocol code
    01/2010
    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 Grant Office, E.O. Ospedali Galliera , S.S. Gestione attività di ricerca e Grant Office, E.O. Ospedali Galliera , 0039 0105634235, ucs@galliera.it
    Scientific contact
    S.S. Gestione attività di ricerca e Grant Office, E.O. Ospedali Galliera , S.S. Gestione attività di ricerca e Grant Office, E.O. Ospedali Galliera , 0039 0105634235, ucs@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
    20 Feb 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    verify the diagnostic efficacy of 18F-DOPA PET/CT compared to traditional imaging methods in the restaging of patients affected by Neuroblastoma
    Protection of trial subjects
    At least 4 months of clinical and imaging follow-up data were available for all patients
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2010
    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: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    1
    Children (2-11 years)
    16
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2
    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 -patients already treated for NB stage IY with confirmed or suspected disease recovery upon clinical, laboratory and conventional imaging evaluation -multi-relapsed patients with ascertained or suspected disease recurrence upon clinical, laboratory and conventional imaging evaluation - Written 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
    		 Neuroblastoma patients who uderwent 18F-DOPA PET/CT
    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
    19
    Completed
    19

    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
    		 19 19
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 1 1
        Adults (18-64 years)
    		 2 2
        children ( 2 - 11 years)
    		 16 16
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    diagnostic accuracy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    diagnostic accuracy

    Subject analysis sets values
    		 diagnostic accuracy
    Number of subjects
    19
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
        Adults (18-64 years)
        children ( 2 - 11 years)
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    4

    End points

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    End points reporting groups
    Reporting group title
    Neuroblastoma patients
    Reporting group description
    		 Neuroblastoma patients who uderwent 18F-DOPA PET/CT

    Subject analysis set title
    diagnostic accuracy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    diagnostic accuracy

    Primary: the diagnostic accuracy of 18F-DOPA-PET/CT compared to 123I-MIBG scintigraphy[1]

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    End point title
    		 the diagnostic accuracy of 18F-DOPA-PET/CT compared to 123I-MIBG scintigraphy[1] [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
    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: for descriptive statistics on continuous data, the indicators used will be mean (for the point estimate) and standard deviation (for the variability of the point estimate) for categorical data used absolute and relative frequency
    End point values
    		 Neuroblastoma patients diagnostic accuracy
    Number of subjects analysed
    19
    19
    Units: MBq/kg megabecquerel(s)/kilogram
    19
    19
    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: no adverse event reported

    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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