<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02976883</url>
  </required_header>
  <id_info>
    <org_study_id>13MP003</org_study_id>
    <nct_id>NCT02976883</nct_id>
  </id_info>
  <brief_title>[18F]HX4 PET/CT Imaging for Detection of Hypoxia</brief_title>
  <acronym>OXYPET</acronym>
  <official_title>A Phase II, Single Centre Exploratory Study of [18F]HX4 PET/CT Imaging to Detect Hypoxia in Patients With Head and Neck and Lung Cancer, Receiving Radiotherapy With Curative Intent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection&#xD;
      of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a&#xD;
      diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up&#xD;
      data will be collected from routine appointments, and analysed with the hypoxia scan results&#xD;
      to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2015</start_date>
  <completion_date type="Actual">July 25, 2017</completion_date>
  <primary_completion_date type="Actual">July 25, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>[18F]HX4 diagnostic PET/CT scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[18F]HX4 (370 MBq) will be administered by a single intravenous injection, after which patients will be required to wait for ≤4.0 h and undergo a PET/CT scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>[18F]HX4 diagnostic PET/CT scan</intervention_name>
    <description>Single intravenous injection of [18F]HX4 and PET/CT scan</description>
    <arm_group_label>[18F]HX4 diagnostic PET/CT scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with:&#xD;
&#xD;
               1. biopsy proven non-small cell carcinoma of the lung &gt;2.5 cm in size with any T and&#xD;
                  N status but M0 who have elected to undergo radical radiotherapy or&#xD;
                  chemo-radiotherapy with curative intent or&#xD;
&#xD;
               2. squamous cell carcinoma of the upper aerodigestive tract with a primary tumour or&#xD;
                  nodal mass &gt;2. 5 cm in size, with any T and N status but M0 who have elected to&#xD;
                  undergo radical radiotherapy or chemo-radiotherapy with curative intent.&#xD;
&#xD;
          -  Participant must be willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Patients must be 18 years old or above.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.&#xD;
&#xD;
          -  Have normal renal function, defined by creatinine clearance of &gt;60 mL/min.&#xD;
&#xD;
          -  Able to remain still in the supine position on the scanner bed for the 40 minute&#xD;
             duration of the examination.&#xD;
&#xD;
          -  Able (in the Investigators opinion) and willing to comply with all study requirements.&#xD;
&#xD;
          -  Willing to allow his or her General Practitioner and hospital consultant, if&#xD;
             appropriate, to be notified of participation in the study&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Patients who are scheduled for surgery prior to radiotherapy will not be included.&#xD;
&#xD;
          -  Female participant who is pregnant, lactating or planning pregnancy during the course&#xD;
             of the study.&#xD;
&#xD;
          -  Chronic kidney disease stage III or worse, as defined by the NKF clinical practice&#xD;
             guidelines (GFR &lt;60 mL/min per 1.73 m3 for 3 months or more).&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of involvement in the study, or may&#xD;
             influence the result of the study, or the participant's ability to participate in the&#xD;
             study.&#xD;
&#xD;
          -  Participants who have been involved in another research study involving an&#xD;
             investigational product in the past 12 weeks.&#xD;
&#xD;
          -  Previous surgery or radiotherapy to the upper aerodigestive tract or lung, which in&#xD;
             the opinion of the Investigators could compromise the data.&#xD;
&#xD;
          -  Previous cancer diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan C Perkins, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nottingham University Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypoxia</keyword>
  <keyword>HX4</keyword>
  <keyword>PET CT</keyword>
  <keyword>Radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02976883
org study id: 13MP003
nct id: NCT02976883
lead sponsor: 
has dmc: No
The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection
      of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a
      diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up
      data will be collected from routine appointments, and analysed with the hypoxia scan results
      to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy
      treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy
time frame: 2 years
measure: Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.
time frame: 5 years
measure: Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images
time frame: 5 years
arm group label: [18F]HX4 diagnostic PET/CT scan
arm group type: Experimental
description: [18F]HX4 (370 MBq) will be administered by a single intravenous injection, after which patients will be required to wait for ≤4.0 h and undergo a PET/CT scan.
intervention type: Other
intervention name: [18F]HX4 diagnostic PET/CT scan
description: Single intravenous injection of [18F]HX4 and PET/CT scan
arm group label: [18F]HX4 diagnostic PET/CT scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan C Perkins, PhD
role: Study Chair
affiliation: Nottingham University Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Hypoxia
sharing ipd: Undecided