xml: <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/NCT06032663</url>
    </required_header>
    <id_info>
      <org_study_id>STH21185</org_study_id>
      <secondary_id>286722</secondary_id>
      <nct_id>NCT06032663</nct_id>
    </id_info>
    <brief_title>Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications</brief_title>
    <official_title>Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary research question to be answered in this project is &quot;Are patients with&#xD;
        locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are&#xD;
        immobilised in a radiotherapy treatment shell?&quot; This will be assessed by measuring the&#xD;
        proportion of patients that complete the full scanning protocol and by obtaining participant&#xD;
        feedback on their experience of completing the scan.&#xD;
  &#xD;
        The secondary question is &quot;Can a PET-MRI scan fused with a planning CT scan improve the&#xD;
        accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be&#xD;
        assessed by:&#xD;
  &#xD;
          1. Comparing the radiotherapy target volumes and radiotherapy plans with and without the&#xD;
             use of a PET-MRI scan.&#xD;
  &#xD;
          2. Comparing inter- and intra-observer variability in treatment contours with and without&#xD;
             the use of a PET-MRI scan within and between oncologists and implications of that.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</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>Completion of PET-MRI</measure>
      <time_frame>12 months</time_frame>
      <description>To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Impact of additional PET-MRI on radiotherapy planning</measure>
      <time_frame>12 months</time_frame>
      <description>The secondary objective is to obtain pilot data on assessing the impact of the additional PET-MRI scan on the precision of radiotherapy planning. This will be assessed by comparing the radiotherapy target volumes and treatment plans with and without the use of PET-MRI scan.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Head and Neck Cancer</condition>
    <arm_group>
      <arm_group_label>PET-MRI within 1 week of planning scan.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients would not normally have a PET-MRI as well as planning scan. In this experimental arm, patients will be given a PET-MRI within 1 week of the planning scan.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>PET-MRI</intervention_name>
      <description>Patients that participate in the current study will have an extra PET-MRI scan, which will expose them to a small amount (4 - 6 mSv) of extra radiation.</description>
      <arm_group_label>PET-MRI within 1 week of planning scan.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 18 years or over&#xD;
  &#xD;
            2. Able to give informed written consent.&#xD;
  &#xD;
            3. New diagnosis of biopsy-proven head and neck cancer.&#xD;
  &#xD;
            4. WHO performance status ≤ 2.&#xD;
  &#xD;
            5. MDT-recommended treatment with radical radiotherapy, with or without concurrent&#xD;
               systemic therapy.&#xD;
  &#xD;
            6. MRI and PET-CT staging scans for diagnosis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast&#xD;
               agents.&#xD;
  &#xD;
            2. Claustrophobia or other contraindications to MRI.&#xD;
  &#xD;
            3. Unable to pass through a 55 cm hula hoop.&#xD;
  &#xD;
            4. Female patients that are pregnant or breastfeeding.&#xD;
  &#xD;
            5. Unable to understand written or spoken English.&#xD;
  &#xD;
            6. Patients not undergoing radical intent radiotherapy.&#xD;
  &#xD;
            7. Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities&#xD;
               e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or&#xD;
               contrast administration.&#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>Satya Garikipati, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>STH Contracted Consultant</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dominic Nash</last_name>
      <phone>01142265208</phone>
      <email>sth.specialisedcancerresearchadministration@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Satya Garikipati, MD</last_name>
      <phone>01142265208</phone>
      <email>s.garikipati@nhs.net</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Head</keyword>
    <keyword>Neck</keyword>
    <keyword>Cancer</keyword>
    <keyword>PET MRI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Head and Neck Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will not be available/shared outside the study</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032663
  org study id: STH21185
  secondary id: 286722
  nct id: NCT06032663
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary research question to be answered in this project is "Are patients with
        locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are
        immobilised in a radiotherapy treatment shell?" This will be assessed by measuring the
        proportion of patients that complete the full scanning protocol and by obtaining participant
        feedback on their experience of completing the scan.
  
        The secondary question is "Can a PET-MRI scan fused with a planning CT scan improve the
        accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be
        assessed by:
  
          1. Comparing the radiotherapy target volumes and radiotherapy plans with and without the
             use of a PET-MRI scan.
  
          2. Comparing inter- and intra-observer variability in treatment contours with and without
             the use of a PET-MRI scan within and between oncologists and implications of that.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Completion of PET-MRI
  time frame: 12 months
  description: To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell.
  measure: Impact of additional PET-MRI on radiotherapy planning
  time frame: 12 months
  description: The secondary objective is to obtain pilot data on assessing the impact of the additional PET-MRI scan on the precision of radiotherapy planning. This will be assessed by comparing the radiotherapy target volumes and treatment plans with and without the use of PET-MRI scan.
  arm group label: PET-MRI within 1 week of planning scan.
  arm group type: Experimental
  description: Patients would not normally have a PET-MRI as well as planning scan. In this experimental arm, patients will be given a PET-MRI within 1 week of the planning scan.
  intervention type: Diagnostic Test
  intervention name: PET-MRI
  description: Patients that participate in the current study will have an extra PET-MRI scan, which will expose them to a small amount (4 - 6 mSv) of extra radiation.
  arm group label: PET-MRI within 1 week of planning scan.
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Satya Garikipati, MD
  role: Principal Investigator
  affiliation: STH Contracted Consultant
  last name: Dominic Nash
  phone: 01142265208
  email: sth.specialisedcancerresearchadministration@nhs.net
  last name: Satya Garikipati, MD
  phone: 01142265208
  email: s.garikipati@nhs.net
  responsible party type: Sponsor
  mesh term: Head and Neck Neoplasms
  sharing ipd: No
  ipd description: IPD will not be available/shared outside the study