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    Clinical Trial Results:
    PROSPECTIVE STUDY OF [68GA]NODAGA-RGD-PET FOR THE DIAGNOSIS OF HEPATOCELLULAR CARCINOMA AND THE ASSESSMENT OF TREATMENT RESPONSE

    Summary
    EudraCT number
    		 2013-003741-42
    Trial protocol
    		 AT  
    Global end of trial date
    01 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2020
    First version publication date
    21 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    31031981
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Innsbruck
    Sponsor organisation address
    Anichstrasse 35, Innsbruck, Austria,
    Public contact
    Armin Finkenstedt, Medizinische Universität Innsbruck, Abteilung für Gastroenterologie und Hepatologie, 0043 512504, armin.finkenstedt@tirol-kliniken.at
    Scientific contact
    Armin Finkenstedt, Medizinische Universität Innsbruck, Abteilung für Gastroenterologie und Hepatologie, 0043 512504, armin.finkenstedt@tirol-kliniken.at
    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
    04 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate accumulation of [68Ga]NODAGA-RGD tracer in HCC compared to the surrounding liver parenchyma and to correlate the tumor volume measured by [68Ga]NODAGA-RGD-PET to the tumor volume measured by CT/MRI.
    Protection of trial subjects
    Data are published in anonymized form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2014
    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
    Austria: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 • Yet untreated HCC due to liver cirrhosis Child Pugh class A or class B. The diagnosis of HCC hast to be confirmed by multiphasic CT or MRI according to EASL/EORTC guidelines. • Written informed consent • Age 18 or above • In women, pregnancy must be excluded and contraception must be performed

    Pre-assignment
    Screening details
    		 • Yet untreated HCC due to liver cirrhosis Child Pugh class A or class B. The diagnosis of HCC hast to be confirmed by multiphasic CT or MRI according to EASL/EORTC guidelines. • Written informed consent • Age 18 or above • In women, pregnancy must be excluded and contraception must be performed

    Pre-assignment period milestones
    Number of subjects started
    		 9
    Number of subjects completed
    		 9

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 only one arm
    Arm description
    		 study arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]NODAGA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    1. Peptide (diagnostic) doses: 20 μg NODAGA-RGD 2. Radiation (imaging) dose: 68Ga @ 150 MBq (±25%) All doses are presented as isotonic sodium chloride solution for intravenous injection.

    Number of subjects in period 1
    		only one arm
    Started
    9
    Completed
    9

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    only one arm
    Reporting group description
    		 study arm

    Primary: To determine the diagnostic accuracy of [68Ga]NODAGA-RGD-PET in patients with HCC in comparison to contrast enhanced CT or MRI

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    End point title
    		 To determine the diagnostic accuracy of [68Ga]NODAGA-RGD-PET in patients with HCC in comparison to contrast enhanced CT or MRI [1]
    End point description
    • Whole body 3D PET/CT images will be acquired at 0-1 h (dynamic) followed by a static scan (6 patients), or 5, 20, 45 and 90 min (static) post-injection (10 patients) with low-dose CT for attenuation and scatter correction (AC, SC). • PET/CT images will be analysed for organ pharmacokinetics, tumour targeting (visual and semi-quantitatively), and internal dosimetry (MIRD). • Serial blood sampling and urine collection to determine tracer stability is carried over 60 min p.i.
    End point type
    Primary
    End point timeframe
    During study
    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: due to study nature no statistical analysis
    End point values
    		 only one arm
    Number of subjects analysed
    9
    Units: radiation
        arithmetic mean (standard deviation)
    1 ( 1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During study participation. No adverse Events have been observed.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1.0
    Frequency threshold for reporting non-serious adverse events: 1%
    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 adverese Events have been observed during the study

    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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