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    Summary
    EudraCT Number:2013-003563-58
    Sponsor's Protocol Code Number:PET_HX4_01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-09
    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 number2013-003563-58
    A.3Full title of the trial
    A Phase II, single-centre exploratory study to assess the value of hypoxia imaging with [18F]HX4 PET/CT in predicting outcome for patients with squamous cell carcinoma of head and neck and non-small cell lung cancer undergoing radical radiotherapy with curative intent
    (OXYPET Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hypoxia PET/CT Scanning in Patients with Cancer, Who are Receiving Radiotherapy (OXYPET Study)
    A.3.2Name or abbreviated title of the trial where available
    [18F]HX4 PET/CT Imaging for Detection of Hypoxia (OXYPET Study) V1
    A.4.1Sponsor's protocol code numberPET_HX4_01
    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 SponsorNottingham University Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 supportPETNET Solutions
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportInHealth PET/CT Centre
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportThreshold Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNottingham University Hospitals NHS Trust
    B.5.2Functional name of contact pointHelen Betts
    B.5.3 Address:
    B.5.3.1Street AddressPET/CT Centre, Gate 1, Hucknall Road, Nottingham City Hospital
    B.5.3.2Town/ cityNottingham
    B.5.3.3Post codeNG5 1PB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01159709172
    B.5.6E-mailhelen.betts2@nuh.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 name[18F]HX4
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[18F]HX4
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive name3-[18F]fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-yl)propan-1-ol
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number333 to 407
    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 Yes
    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
    Patients with either:
    (a) non small cell lung carcinoma, or
    (b) squamous cell carcinoma of the upper aerodigestive tract
    Patients with distant metastases will not be included.
    E.1.1.1Medical condition in easily understood language
    Patients with either:
    (a) lung cancer
    (b) head and neck cancer
    Patients whose cancer has spread to other parts of the body will not be included.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Do the scan results from the hypoxia imaging (HX4 PET/CT) predict patient outcome two years after treatment?
    E.2.2Secondary objectives of the trial
    Do the scan results from the hypoxia imaging (HX4 PET/CT) predict patient outcome five years after treatment?

    Do the scan results from the hypoxia imaging (HX4 PET/CT) give a different indication of patient outcome than the routinely used radiotracer fluorodeoxyglucose (FDG)? FDG is a radiotracer that shows how the body processes sugar, but does not show how the body uses oxygen.

    Does the tumour size correlate with the intensity of HX4 uptake?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with:

    (a) biopsy proven non-small cell carcinoma of the lung >2.5 cm in size with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent or
    (b) squamous cell carcinoma of the upper aerodigestive tract (excluding oesophagus) with a primary tumour or nodal mass >2.5 cm in size, with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent.

    • Participant must be willing and able to give informed consent for participation in the study.

    • Patients must be 18 years old or above.

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

    • Have adequate renal function, defined by creatinine clearance of >30 mL/min.

    • Able to remain still in the supine position on the scanner bed for the 40 minute duration of the examination.

    • Able (in the Investigators opinion) and willing to comply with all study requirements.

    • Willing to allow his or her General Practitioner and hospital consultant to be notified of participation in the study.
    E.4Principal exclusion criteria
    • Female participant who is pregnant, lactating or planning pregnancy during the course of the study.

    • Chronic kidney disease stage III or worse, as defined by the NKF clinical practice guidelines.

    • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of involvement in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

    • Participants who have been involved in another research study involving an investigational product in the past 12 weeks.

    • Previous surgery or radiotherapy to the upper aerodigestive tract or lung, which in the opinion of the Investigators could compromise the data.

    • Patient is a prisoner.

    • Previous cancer diagnosis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be data collection to determine the number of participants with:
    (a) primary treatment failure
    (b) tumour recurrence
    (c) disease free survival
    in the first two years after radiotherapy treatment, as assessed in routine clinical and imaging follow-up appointments. Distribution of participants into these groups will be analysed in relation to the [18F]HX4 PET/CT scan results.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient outcome data will be gathered for two years after completion of radiotherapy treatment.
    E.5.2Secondary end point(s)
    The secondary endpoints will be:

    (i) Collection of outcome data to determine number of participants with:
    (a) tumour recurrence
    (b) disease free survival
    up to five years after radiotherapy treatment. The distribution of participants in these groups will be assessed in relation to the [18F]HX4 PET/CT scan results.

    (ii) Comparison of pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images (obtained within a month of each other) in relation to the outcome data, to determine if there is extra value in [18F]HX4 imaging over [18F]FDG imaging for predicting patient outcome.

    (iii) Comparison of primary tumour and nodal disease site sizes (from pre-treatment contrast enhanced CT or MRI, where available) with the [18F]HX4 intensity in the corresponding areas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient outcome data will be collected for five years after radiotherapy treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 will be the collection of the five year follow up data for the final participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    A single diagnostic PET/CT scan with HX4 is being investigated, and therefore continuation after the trial is not applicable.
    No changes to the expected normal treatment will be made.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-25
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