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    Clinical Trial Results:
    Evaluation of [11C]-methionine positron emission computerised tomography (PET CT) in diagnosing neurofibromatosis 1(NF1) - malignant peripheral nerve sheath tumours (MPNST)

    Summary
    EudraCT number
    		 2010-019759-23
    Trial protocol
    		 GB  
    Global end of trial date
    09 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Oct 2018
    First version publication date
    17 Oct 2018
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    PET-CT140410
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Professor Rosalie Ferner, Guy's and St Thomas' NHS Foundation Trust, 0044 02071883970 , rosalie.ferner@kcl.ac.uk
    Scientific contact
    Professor Rosalie Ferner, Guy's and St Thomas' NHS Foundation Trust, 0044 02071883970 , rosalie.ferner@kcl.ac.uk
    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
    26 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    1) To evaluate whether [11C]-methionine is more sensitive and specific than FDG PET CT in evaluating malignant transformation of plexiform neurofibromas in NF1 patients.
    Protection of trial subjects
    All patients will be followed for reporting of adverse events (AEs) from when the informed consent is signed until the telephone call on the day following the PET CT. If there are AEs that occurred while the patient was on study which are attributed (almost certainly, probably or possibly imaging agent-related) to [11C]-methionine, and are still present on the follow-up phone call, the patient will be followed monthly until resolution or stabilisation of these events.
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2012
    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
    United Kingdom: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 5 subjects were recruited to this trial within the United Kingdom

    Pre-assignment
    Screening details
    		 Twenty two individuals were assessed & failed screening

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

    Arms
    Arm title
    		 All Participants
    Arm description
    		 AEs and concomitant medications must be assessed prior to administration of the first imaging agent [11C]-methionine. AEs must be assessed throughout the patient’s time in the PET Imaging Centre. [11C]-methionine imaging: • Patients must fast starting 4 hours prior to [11C]-methionine administration (Time = T0), until after their scan (Time = T0+1). Patients may drink water throughout this period of approximately 5 hours of fasting. • An intravenous injection of 800 MBq (± 10%) [11]C-methionine will be administered (Time = T0) in accordance with section 6.1.4 “[11C]-methionine Administration”. A 40-minute dynamic PET acquisition scan over the lesion will be performed. After this the patient may get up off the scanning couch, have a drink of water and use the toilet.
    Arm type
    		 Experimental

    Investigational medicinal product name
    [11]C-methionine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Radiopharmaceutical precursor
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    intravenous injection of 800 MBq (± 10%) [11]C-methionine

    Number of subjects in period 1
    		All Participants
    Started
    5
    Completed
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study Intervention
    Reporting group description
    		 -

    Reporting group values
    		 Study Intervention Total
    Number of subjects
    		 5 5
    Age categorical
    Patients with suspected malignant transformation of their plexiform neurofibromas will be enrolled. Each patient will participate in the trial for approximately 1 week.
    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)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    All Participants
    Reporting group description
    		 AEs and concomitant medications must be assessed prior to administration of the first imaging agent [11C]-methionine. AEs must be assessed throughout the patient’s time in the PET Imaging Centre. [11C]-methionine imaging: • Patients must fast starting 4 hours prior to [11C]-methionine administration (Time = T0), until after their scan (Time = T0+1). Patients may drink water throughout this period of approximately 5 hours of fasting. • An intravenous injection of 800 MBq (± 10%) [11]C-methionine will be administered (Time = T0) in accordance with section 6.1.4 “[11C]-methionine Administration”. A 40-minute dynamic PET acquisition scan over the lesion will be performed. After this the patient may get up off the scanning couch, have a drink of water and use the toilet.

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint [1]
    End point description
    Evaluation of [11C]-Methionine PET CT in the diagnosis of neurofibromatosis 1 (NF1)- malignant peripheral nerve sheath tumours (MPNST). Improvement of identification of NF1 patients with malignant transformation of symptomatic plexiform neurofibromas compared with FDG PET CT.
    End point type
    Primary
    End point timeframe
    Duration of trial
    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: Trial was terminated early after only 5 participants enrolled. Please see attached document for results.
    End point values
    		 All Participants
    Number of subjects analysed
    5
    Units: whole
    5
    No statistical analyses for this end point

    Secondary: Secondary Outco,es

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    End point title
    		 Secondary Outco,es
    End point description
    To compare the semi-quantitative uptake of methionine with genetic analysis of the NF1- MPNST
    End point type
    Secondary
    End point timeframe
    Duration of trial interventions
    End point values
    		 All Participants
    Number of subjects analysed
    5
    Units: whole
    5
    No statistical analyses for this end point

    Secondary: Secondary Outcomes

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    End point title
    		 Secondary Outcomes
    End point description
    To assess the safety of [11C]- methionine in patients with NF1 who are at risk of malignant transformation of plexiform neurofibromas to MPNST
    End point type
    Secondary
    End point timeframe
    Duration of trial intervention
    End point values
    		 All Participants
    Number of subjects analysed
    5
    Units: whole
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From consent to post methionine until their Off-Study telephone assessment after administration of [11C]-methionine.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Whole Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Whole Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Whole Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    Investigations
    Discomfort at venesection site.
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1

    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.
    Trial was terminated early due to technical problems with inadequate yield of [11C]-Methionine & significant difficulties in recruiting patients with this rare disease complication with stringent inclusion criteria. 5 subjects were recruited only.
    For support, Contact us.
    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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