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    Clinical Trial Results:
    Prognostic value of 18F-FAZA PET/CT in high grade glioma: comparison with MRI and correlation with hypoxia biomarkers.

    Summary
    EudraCT number
    		 2015-000679-28
    Trial protocol
    		 IT  
    Global end of trial date
    09 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2022
    First version publication date
    19 Oct 2022
    Other versions
    Summary report(s)
    		 Summary results FAZA-gliomi_
    End of study communication
    DSUR
    Article_Nuclear Medicine Communication_28 January 2021_M.Picchio
    Mapelli 2020 CNM_Hypoxia_and_Amino_Acid_Imaging_of_High_Grade.39
    Mapelli2017_FAZA_RT_ClinNuclMed
    Mapelli2017_FAZA_RT_ClinNuclMed
    Mapelli2020_faza_focus on HGG_IJBM
    MAPELLI2021_ 18F_FAZA_PET_CT_in_pretreatment_assessment_of
    Quartuccio2020_CATI2020_Hypoxia

    Trial information

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    Trial identification
    Sponsor protocol code
    FAZA-gliomi
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS Ospedale San Raffaele
    Sponsor organisation address
    Via Olgettina n.60, Milan, Italy, 20132
    Public contact
    MEDICINA NUCLEARE, IRCCS OSPEDALE SAN RAFFAELE, 0039 02-26436117, picchio.maria@hsr.it
    Scientific contact
    MEDICINA NUCLEARE, IRCCS OSPEDALE SAN RAFFAELE, 0039 02-26436117, picchio.maria@hsr.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
    09 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To define the role of PET/CT with 18F-FAZA as a guide to biopsy, to predict patient outcomes, to define the correlation between spatial pseudoprogressione disease / radiation necrosis and hypoxia and to plan radiotherapy treatment in patients with high-grade gliomas.
    Protection of trial subjects
    N.A.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Apr 2016
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    12
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with brain MRI suggestive for High Grade Glioma

    Pre-assignment
    Screening details
    		 In this prospective clinical study, 20 patients with brain MRI suggestive for HGG have been enrolled from April 2016 to October 2017 at IRCCS OSR. The study population consisted of 13 male and 5 female patients, with a mean age of 66years (range 41–81).

    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
    		 Arm 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    18F-labeled fluoroazomycinarabinoside
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    370 MBq megabecquerel(s) die

    Investigational medicinal product name
    18F-labeled fluoroazomycinarabinoside
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infusion
    Dosage and administration details
    370 MBq megabecquerel(s) die

    Number of subjects in period 1 [1]
    		Arm 1
    Started
    18
    Completed
    18
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: All recruited patients underwent 18F-FAZA PET/CT before starting treatment, with the exception of two patients dropped out because of technical issues regarding radiotracer synthesis.

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 -

    Primary: Value of 18F-FAZA PET/CT in high-grade glioma

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    End point title
    		 Value of 18F-FAZA PET/CT in high-grade glioma [1]
    End point description
    End point type
    Primary
    End point timeframe
    All study duration
    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: Correlations between all PET-derived parameters and anatomopathological features (CA-IX, GLUT-1, average number of capillaries, anti-CD31 antibody and Ki-67) were evaluated by using the nonparametric Spearman’s correlation coefficient. For patients with multiple lesions, only PET data of the main lesion were used for computing the correlations. The correlation analysis was performed separately for the two subgroups (surgical and bioptic).
    End point values
    		 Arm 1
    Number of subjects analysed
    18
    Units: 1
        number (not applicable)
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    First patient first visit: 08/04/2016 Last recruitment date: 12/10/2017 Study closure: 09/04/2018
    Adverse event reporting additional description
    No adverse events related to the experimentation occurred during the study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    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: In this study there are not non serious adverse event (SAE). See DSUR in attach

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Sep 2016
    The protocol has been amended in ordet to include patients with high-grade Glioma both candidate to stereotactic biopsy and surgical intervention.

    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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