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    Clinical Trial Results:
    Phase II trial: RGD PET/MRI in sporadic Vestibular Schwannoma

    Summary
    EudraCT number
    		 2017-002604-27
    Trial protocol
    		 DK  
    Global end of trial date
    16 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2023
    First version publication date
    12 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PCT2017-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03393689
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen OE, Denmark, 2100
    Public contact
    Hjalte Christian Reeberg Sass, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology , 0045 31310730, hjaltesass@gmail.com
    Scientific contact
    Hjalte Christian Reeberg Sass, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology , 31310730 31310730, hjaltesass@gmail.com
    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
    08 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objektive of this study is to test whether the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenises. The tracer combined with PET-MR has the potential to provide a novel non-invasive prognostic method for the growth rate of vestibularis schwannomas, as the growth rate of vestibularis schwannomas has been correlated with pro-angiogenetic markers. This is a phase II trial in patients with a benign intracranial tumor. Uptake of the tracer will be correlated to the growth rate by PET-MR and MR scans.
    Protection of trial subjects
    The information regarding included patietns are protected by the health care legislation. Source data i saved in a electronic database, and is pseudoanonymised. Kildedata (og CRF) gemmes i selvstændig mappe og overføres til en elektronisk database. Patientdata is protected throgh Pseudonymization and is kept in 10 years.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    24
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients are included via the department of Otolaryngologi, Head & Neck surgery, Rigshospitalet and from the department of Audiology at Hillerød Hospital. 40 patients are included over a period expected to last 12 months.

    Pre-assignment
    Screening details
    		 Inclusion criteria. Patients > 18 years of age with an MRI diagnosed sporadic vestibular shcwannoma. Patients > 18 år with a maximal Wachful Waiting Regime of 12 months or 1 follow-up MRI. Exclusion criteria. Pregnancy, lactation, Non-MRI compatible implants, Claustrofobia, Hormone-treatment, Steroidtreatment, weight > 140, allergy to PET-tracer

    Period 1
    Period 1 title
    Intevention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was a non-blinded non-randomized phase two clinical trial

    Arms
    Arm title
    		 Intervention
    Arm description
    		 PET-MRI scan with novel PET-Tracer. Follow-up MRI-scans with gadolinium contrast after 6 months and 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]NOTA -Asp-Cha-Phe-D-Ser-D-Arg-Tyr-Leu-Trp-Ser-OH
    Investigational medicinal product code
    Other name
    68Ga-NODAGA-E[c(RGDyK)]2, RGD
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Injection of 200 mBq through a peripheral venous catheter.

    Number of subjects in period 1
    		Intervention
    Started
    43
    Follow up Scan
    37
    Completed
    37
    Not completed
    6
         Not able to perform scan due to claustrophobia
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intevention (overall period)
    Reporting group description
    		 Patients newly diagnosed with a vestibular schwannoma, where knowledge regarding the potential growth of the schwannoma is not known.

    Reporting group values
    		 Intevention (overall period) Total
    Number of subjects
    		 43 43
    Age categorical
    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)
    		 24 24
        From 65-84 years
    		 19 19
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 60 (30 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 PET-MRI scan with novel PET-Tracer. Follow-up MRI-scans with gadolinium contrast after 6 months and 12 months.

    Primary: SUV uptake correlated to growth rate

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    End point title
    		 SUV uptake correlated to growth rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    Patients are followed for a minimum of 12 months after primary PET-MRI scan, with follow-up scans.
    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: Data analysis has been performed and will be published in a peer-reviewed article soon. Full data is available as uploaded as an XML document.
    End point values
    		 Intervention
    Number of subjects analysed
    37
    Units: Uptake correlated to growth
    number (not applicable)
        SUV uptake correlated to growth
    37
    Attachments
    		 Untitled (Filename: Resultater.xlsx)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The timeframe for the adverse events reporting was within the first 24-hours of administering the novel PET-tracer, RGD.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Internvention
    Reporting group description
    		 -

    Serious adverse events
    		 Internvention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Internvention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    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: We did not see any adverse events during the 24-hour reporting timeframe.

    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.
    Limitations include the values of the SUV uptake in the smaller tumors as well as the genereal limitation in ROI-drawing, despite being done by two skilled radiologist.
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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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