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    Summary
    EudraCT Number:2011-002028-41
    Sponsor's Protocol Code Number:HPX-2011-003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-02-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-002028-41
    A.3Full title of the trial
    A study to determine regional lung function in patients with Non-small cell lung cancer (NSCLC) undegoing radiotherapy using hyperpolarised xenon gas MR imaging
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lung imaging using hyperpolarized xenon gas MR imaging in patients with lung cancer after radiotherapy
    A.3.2Name or abbreviated title of the trial where available
    Hyperpolarized xenon gas MR imaging in NSCLC Radiotherapy
    A.4.1Sponsor's protocol code numberHPX-2011-003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOxford University Hospitals NHS Trust
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR Oxford Biomedical Research Centre
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOxford Biomedical Research Centre
    B.5.2Functional name of contact pointProgramme Director
    B.5.3 Address:
    B.5.3.1Street AddressChurchill Hospital, Old Road
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7LE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865572691
    B.5.6E-mailjenni.lee@ouh.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHyperpolarized Xenon gas
    D.3.2Product code HypXe
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHyperpolarized xenon
    D.3.9.2Current sponsor codeHypXe
    D.3.9.3Other descriptive nameHyperpolarized xenon gas for inhalation
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit l litre(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100% to xenon
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-small cell lung cancer.
    E.1.1.1Medical condition in easily understood language
    Lung cancer, this is the most common type
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To demonstrate that hyperpolarized Xe-129 is sensitive to change at 3 months following radiotherapy, and thus may be developed as an objective and quantifiable method of functional lung assessment in patients with NSCLC undergoing radiotherapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives are: -
    • To demonstrate that hyperpolarized Xe-129 is sensitive to change at other time points from two weeks after commencement of radiotherapy schedules to one year following completion of radiotherapy.
    • To obtain preliminary data demonstrating if baseline hyperpolarized Xe-129 MR imaging is a more reliable clinical indicator of patient respiratory tolerance for NSCLC radical radiotherapy than conventional lung function testing by determining the relationship between MR imaging indices and functional patient outcome measures (exercise ability, dyspnoea and radiation-induced lung toxicity assessment).
    • To obtain preliminary data demonstrating if changes in hyperpolarized Xe-129 MR imaging objectively and quantifiably assess lung function (ventilation and perfusion) responses following NSCLC radiotherapy.
    • To use functional lung information in virtual predictive and adaptive radiotherapy treatment planning.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study participants with any stage NSCLC considered suitable for radical radiotherapy (with either conventionally fractionated treatment or with stereotactic body radiotherapy (SABR)) or chemoradiotherapy (concurrent or sequential schedule) will be recruited.

    Inclusion Criteria
    • Participant is willing and able to give informed consent for participation in the study.
    • Male or Female, aged 18 years or above.
    • Histologically verified NSCLC.
    • Patients with any stage NSCLC where radical radiotherapy (with either conventionally fractionated treatment or with stereotactic body radiotherapy (SABR)) or chemoradiotherapy (concurrent or sequential schedule) is considered appropriate.
    • WHO performance status 0-2
    • Able (in the Investigators opinion) and willing to comply with all study requirements.
    E.4Principal exclusion criteria
    Exclusion Criteria
    The participant may not enter the study if ANY of the following apply:
    • Inability to give written informed consent.
    • Female participants who are pregnant, lactating or planning pregnancy
    during the course of the trial
    • Previous radiotherapy to the chest.
    • The presence of another condition where the disease itself or treatment may interfere with the study endpoints.
    • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    • Inability to lie flat for imaging.
    • Contraindications to MRI examination including indwelling pacemaker, non-MRI compatible metallic implant, severe claustrophobia, intra-ocular foreign body.
    • Contraindications for gadolinium enhanced lung MRI scan – known hypersensitivity/allergy to the injection of MultiHance (contains gadobenate dimeglumine and small quantities of benzyl alcohol) that is given as part of this scanning or an adverse reaction to an injection given during previous MRI scanning, severe renal impairment.
    • Contraindications for ventilation/perfusion nuclear medicine scanning – known hypersensitivity to albumin or preference to avoid blood donation product.
    • Epilepsy requiring on-going medical treatment, or a seizure within the past year.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in ventilation and ADC maps using hyperpolarized Xe-129 MR imaging from baseline to 3 months post radiotherapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time point for evaluation of this end point is 3 months after starting radiotherapy treatment.
    E.5.2Secondary end point(s)
    Secondary Endpoints
    • Change in ventilation and ADC maps using hyperpolarized Xe-129 MR imaging from baseline to other time points post radiotherapy initiation.
    • Change in lung perfusion and other lung MR imaging parameters from baseline to other time points post radiotherapy initiation.
    • Correlation between change in ventilation/ ADC maps using hyperpolarized Xe-129 MR imaging and change in lung function from baseline to each time point.
    • Demonstration of superior correlation of functional patient outcome measures (dyspnoea, quality of life and exercise ability) with ventilation and ADC maps than with lung function.
    • Comparison of hyperpolarized Xe-129 MR imaging and four-dimensional CT (4D-CT) at baseline. 4D-CT is performed in by the treating Oncologist in the Radiotherapy department for RT planning purposes. The scan is part of routine care and not a study measure, although data will be analysed from this scan to achieve this endpoint.

    Exploratory Endpoints
    • Retrospective comparison of modified radiotherapy treatment planning incorporating functional lung information from hyperpolarized Xe-129 MR imaging with conventional radiotherapy treatment plans.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time points for evaluation of secondary end points are two weeks after commencement of radiotherapy, on the final day of treatment, 3 months, 6 months and 1 year after treatment initiation.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Imaging Study
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is the date of the last hospital visit of the last participant.
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All participants will receive best standard care throughout and this will continue without interference following trial completion. The study will provide additional scans to investigate their response to treatment. The importance of this is not yet known, but the most likely period of benefit would be within 1 year of treatment, ie during the study period. Therefore no continued provision is planned.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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