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    Clinical Trial Results:
    Lung HeXeRT: Advanced proton, hyperpolarised 3helium and 129xenon magnetic resonance imaging for lung cancer radiotherapy planning and evaluation

    Summary
    EudraCT number
    		 2013-004837-34
    Trial protocol
    		 GB  
    Global end of trial date
    08 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2022
    First version publication date
    10 Sep 2022
    Other versions
    Summary report(s)
    		 Paper 2 Results

    Trial information

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    Trial identification
    Sponsor protocol code
    STH17245
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01859650
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    Trust Headquarters, 8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    Scientific contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    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 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To develop and evaluate the use of advanced magnetic resonance imaging (MRI) techniques for patients with lung cancer undergoing radiotherapy. 1. To test the use of new MRI methods in treatment planning and for evaluating the treatment.
    Protection of trial subjects
    All participants were given a participant information sheet to read and consider for at least 24 hours before attending for a screening visit for the study. Participants were reviewed by a clinician who was delegated to this task, according to the strict inclusion and exclusion criteria. All participants give written informed consent prior to enrolment to the study. GCP procedures were in place to ensure appropriate consent, confidentiality and privacy. Data were handled in accordance with the Data Protection Act. During the MR imaging procedure some patients may become claustrophobic whilst inside the scanning machine. In addition the injection of the contrast agent Gadovist may in some cases produce side effects. One of the IMPs Xenon gas has potential mild anaesthetic side effects. To minimise these risks all patients are assessed using an MRI safety screening questionnaire as for MR imaging in clinical practice, and all patients are informed about the process of MR scanning and potential side effects in the patient information sheet for the trial. During the imaging process the patients are carefully monitored. Patients who experience any side effects will be followed up by the responsible physician.
    Background therapy
    		 -
    Evidence for comparator
    		 There are no comparators in the trial. The Investigative Medicinal Products are: Xenon 129 and 3 Helium which are both hyperpolarised gasses which are inhaled by patients to enhance MR images of the lungs. Oxygen gas, given to patients to enhance MR imaging. Gadovist, a contrast agent dye given to patients to enhance MR imaging.
    Actual start date of recruitment
    11 Dec 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
    United Kingdom: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Territory: single site study in Sheffield, UK.

    Pre-assignment
    Screening details
    		 Participants were screened according to eligibility criteria

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Arm title
    		 Arm 1
    Arm description
    		 This is a non-randomised study of up to 22 subjects using hyperpolarised gas (3He and 129Xe), proton MR imaging and whole lung physiology methods (including multi breath washout)
    Arm type
    		 Experimental

    Investigational medicinal product name
    3 Helium gas
    Investigational medicinal product code
    MIA(IMP)29724
    Other name
    Helispin
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    add from protocol

    Investigational medicinal product name
    Xenon 129 gas
    Investigational medicinal product code
    MIA(IMP)29724
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    add from protocol

    Investigational medicinal product name
    compressed medical oxygen
    Investigational medicinal product code
    PL 00735/5000, V03AN01
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    Oxygen is an IMP involved in the generation of MRI scans. During an MR imaging session, the subject will alternately breathe room air and up to 39.75 litres of 100% 02. It is classified as IMP in these studies but are “off the shelf” products being used unmodified with no special labelling and no special storage requirements. Medical oxygen is administered by inhalation through the lungs.

    Investigational medicinal product name
    Gadovist
    Investigational medicinal product code
    PL 00010/0535, V08C A09
    Other name
    Gadovist 1.0 mmol/ml solution for injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.05 ml per kg body weight of 1.0 mmol Gadovist via a power injector followed by a 20 ml saline flush. One dose of Gadovist per imaging session.

    Number of subjects in period 1
    		Arm 1
    Started
    22
    Completed
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 22 22
    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)
    		 22 22
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 This is a non-randomised study of up to 22 subjects using hyperpolarised gas (3He and 129Xe), proton MR imaging and whole lung physiology methods (including multi breath washout)

    Primary: End Points Supplied in Published Papers

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    End point title
    		 End Points Supplied in Published Papers [1]
    End point description
    End point type
    Primary
    End point timeframe
    Whole 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: Statistical analyses not suitable for this end point
    End point values
    		 Arm 1
    Number of subjects analysed
    1 [2]
    Units: .
    1
    Notes
    [2] - End points supplied in published papers
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAE reporting period is within 28 days of IMP administration.
    Adverse event reporting additional description
    SAEs occurring outside of day 0-28 window will be exempt from immediate reporting and will not be recorded on CRF. Events otherwise meeting the criteria for SAEs but relating to specific criteria in protocol will not be reported as SAE and details will not be transcribed onto the case report form as an SAE; these events will be recorded in notes.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    All enrolled
    Reporting group description
    		 -

    Serious adverse events
    		 All enrolled
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All enrolled
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 22 (63.64%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastasis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    Investigations
    CT scan abnormal
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Abnormal LFTs
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Cardiac disorders
    Angina
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Nervous system disorders
    Vasovagal attack
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    Numbness
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Gastrointestinal disorders
    Indigestion
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    COPD exacerbation
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Shoulder pain
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Arthritis rheumatoid
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Infections and infestations
    Chest infection
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hyponatremia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Decreased appetite
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2016
    Clarification of hospitilisation criteria reporting of SAE's. Clarification that the gas MRI imaging sequence consists of a calibration scan and main scan: a small dose followed by the main imaging dose and and removal of number of doses of Xenon and Helium allowable whilst keeping the total maximum IMP exposure within the limits approved by the MHRA. Confirmation of the method of delivery of oxygen treatment, confirming that only a proportion of oxygen dispensed will be inhaled and confirming the flow rate and maximum time for which oxygen will be administered.

    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 of EudraCT system to report results of this study type.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30355463
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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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