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/NCT06035653</url>
    </required_header>
    <id_info>
      <org_study_id>RD2021-57</org_study_id>
      <nct_id>NCT06035653</nct_id>
    </id_info>
    <brief_title>A Human Versus Machine Comparison Study</brief_title>
    <acronym>HuVeM</acronym>
    <official_title>A Step Towards Fully Automated Adaptive Radiotherapy in Head &amp; Neck Cancer: A Human Versus Machine Comparison Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>East and North Hertfordshire NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>East and North Hertfordshire NHS Trust</source>
    <oversight_info>
      <has_dmc>Yes</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 study aims to retrospectively, and anonymously analyse the data of patients treated over&#xD;
        a period of 12 months. These are the patients whose radiotherapy plan were needed to be&#xD;
        reviewed in the weekly on-treatment head and neck multi-professional radiotherapy meeting&#xD;
        during the course of their radiation.&#xD;
  &#xD;
        Collected clinical data will be included in the retrospective analysis, comparing the&#xD;
        clinical decision (gold standard of care), against the predictive capability of intelligence&#xD;
        software&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single centre, non-interventional study comparing &quot;machine&quot; against clinician's&#xD;
        standard of care approach. The utilisation of intelligence software is for research purposes&#xD;
        only and does not permit active changes to patients' clinical management. Any software&#xD;
        related analyses will be done after patients have completed radiation treatment.&#xD;
  &#xD;
        All consented patients who were discussed in the head and neck CBCT meeting and deemed to&#xD;
        require new masks / recontouring / replanning - Cohort A will be analysed on completion of&#xD;
        radiotherapy. These patients typically are ones with nodal disease of &gt;3cm at presentation,&#xD;
        and whose weight change is notable 5 - 10% of baseline in the first 2 weeks of their&#xD;
        treatment. There have been 28 patients in 12 months previously.&#xD;
  &#xD;
        Other patients discussed in the head and neck CBCT meeting on completion of radiation -&#xD;
        Cohort B, whose radiotherapy was not deemed to require total replan but were clinically&#xD;
        deemed 'marginal' will be included. These patients tend to be ones with weight loss measuring&#xD;
        close to 1.29cm lateral separation or between the skin surface and the head shell.&#xD;
  &#xD;
        The radiotherapy replan volumes CTVs of Cohort A patients will retrospectively compared to&#xD;
        the CTVs produced by the intelligence software. The time using the software to produce&#xD;
        dynamic CTVs will be compared with the time needed for the clinicians to create new CTV for&#xD;
        the radiotherapy replan, which will be recorded prospectively.&#xD;
  &#xD;
        The CBCTs of both Cohorts A &amp; B will be analysed using the intelligence software to determine&#xD;
        the adequacy of PTV coverage. This is to be compared with the departmental quality&#xD;
        assurance/audit of PTV margins.&#xD;
  &#xD;
        The software will also be used to calculate various aspects of the radiotherapy plans,&#xD;
        including the cumulative dose distribution over the period of dynamic anatomical change&#xD;
        Cohorts A &amp; B.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 3, 2023</start_date>
    <completion_date type="Anticipated">November 27, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 27, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by volume differences</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Sorensen-DICE Coefficient</measure>
      <time_frame>1 year</time_frame>
      <description>Measurement of ratio of overlap</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Discordance Index</measure>
      <time_frame>1 year</time_frame>
      <description>Measurement of over contouring</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Geographical miss index</measure>
      <time_frame>1 year</time_frame>
      <description>Measurement of under contouring</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Hausdorff distance</measure>
      <time_frame>1 year</time_frame>
      <description>Measurement of distance between 2 volumes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PTV margins compared against the departmental standards</measure>
      <time_frame>1 year</time_frame>
      <description>Proportion of clinical tumour volume covered by different radiotherapy set up margins 3, 4 and 5mm</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Potential time saved recontouring with software and the associated cost of re-planning adaptive radiotherapy</measure>
      <time_frame>1 year</time_frame>
      <description>Difference between time spent on re- contouring and time spent on editing software deformed CTVs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of clinical decision on total radiotherapy re-plan</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by retrospective assessment of dose accumulation of the CTVs</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Head and Neck Cancer</condition>
    <arm_group>
      <arm_group_label>A</arm_group_label>
      <description>Minimum of 12 patients who required total radiotherapy replan</description>
    </arm_group>
    <arm_group>
      <arm_group_label>B</arm_group_label>
      <description>Minimum of 28 patients who were reviewed in the multi-professional meeting but did not require full replan</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Minimum of 12 patients who required total radiotherapy replan (Cohort A) Minimum of 28&#xD;
          patients who were reviewed in the multi-professional meeting but did not require full&#xD;
          replan (Cohort B) Minimum of 40 patients in total (Cohorts A&amp;B).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  i. Head and neck cancer patients who require new mask for radiotherapy replanning will&#xD;
               be included (Cohort A). These patients typically are ones with rapid shrinkage of the&#xD;
               nodal disease, or whose weight change is notable (5 - 10% of baseline) in the first 2&#xD;
               weeks of radiotherapy ii. Patients on close observation of the head and neck&#xD;
               multi-professional team but whose radiotherapy did no undergo total replan treatment&#xD;
               will be included (Cohort B)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          i. Patients whose primary malignancy is not of head and neck origin ii. Patients who&#xD;
          specifically opt against their information be used anonymously iii. Head and neck cancer&#xD;
          patients whose radiotherapy plans did not require review in the head and neck&#xD;
          multi-professional radiotherapy meeting iv. Patients under the age of 18&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Kevin Chiu</last_name>
      <phone>0203 826 2020</phone>
      <email>k.chiu@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rishma Bhatti</last_name>
      <phone>0203 826 2020</phone>
      <email>mvccresearch.enh-tr@nhs.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>East &amp; North Hertfordshire NHS Trust</name>
        <address>
          <city>Northwood</city>
          <state>UK</state>
          <zip>HA6 2RN</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kevin Chiu, CI</last_name>
        <phone>02038262020</phone>
        <email>k.chiu@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>Rishma Bhatti</last_name>
        <phone>02038262020</phone>
        <email>mvccresearch.enh-tr@nhs.net</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
    </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/NCT06035653
  org study id: RD2021-57
  nct id: NCT06035653
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to retrospectively, and anonymously analyse the data of patients treated over
        a period of 12 months. These are the patients whose radiotherapy plan were needed to be
        reviewed in the weekly on-treatment head and neck multi-professional radiotherapy meeting
        during the course of their radiation.
  
        Collected clinical data will be included in the retrospective analysis, comparing the
        clinical decision (gold standard of care), against the predictive capability of intelligence
        software
  This is a single centre, non-interventional study comparing "machine" against clinician's
        standard of care approach. The utilisation of intelligence software is for research purposes
        only and does not permit active changes to patients' clinical management. Any software
        related analyses will be done after patients have completed radiation treatment.
  
        All consented patients who were discussed in the head and neck CBCT meeting and deemed to
        require new masks / recontouring / replanning - Cohort A will be analysed on completion of
        radiotherapy. These patients typically are ones with nodal disease of >3cm at presentation,
        and whose weight change is notable 5 - 10% of baseline in the first 2 weeks of their
        treatment. There have been 28 patients in 12 months previously.
  
        Other patients discussed in the head and neck CBCT meeting on completion of radiation -
        Cohort B, whose radiotherapy was not deemed to require total replan but were clinically
        deemed 'marginal' will be included. These patients tend to be ones with weight loss measuring
        close to 1.29cm lateral separation or between the skin surface and the head shell.
  
        The radiotherapy replan volumes CTVs of Cohort A patients will retrospectively compared to
        the CTVs produced by the intelligence software. The time using the software to produce
        dynamic CTVs will be compared with the time needed for the clinicians to create new CTV for
        the radiotherapy replan, which will be recorded prospectively.
  
        The CBCTs of both Cohorts A & B will be analysed using the intelligence software to determine
        the adequacy of PTV coverage. This is to be compared with the departmental quality
        assurance/audit of PTV margins.
  
        The software will also be used to calculate various aspects of the radiotherapy plans,
        including the cumulative dose distribution over the period of dynamic anatomical change
        Cohorts A & B.
  observational model: Cohort
  time perspective: Retrospective
  measure: Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs
  time frame: 1 year
  description: Measured by volume differences
  measure: Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Sorensen-DICE Coefficient
  time frame: 1 year
  description: Measurement of ratio of overlap
  measure: Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Discordance Index
  time frame: 1 year
  description: Measurement of over contouring
  measure: Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Geographical miss index
  time frame: 1 year
  description: Measurement of under contouring
  measure: Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Hausdorff distance
  time frame: 1 year
  description: Measurement of distance between 2 volumes
  measure: PTV margins compared against the departmental standards
  time frame: 1 year
  description: Proportion of clinical tumour volume covered by different radiotherapy set up margins 3, 4 and 5mm
  measure: Potential time saved recontouring with software and the associated cost of re-planning adaptive radiotherapy
  time frame: 1 year
  description: Difference between time spent on re- contouring and time spent on editing software deformed CTVs
  measure: Evaluation of clinical decision on total radiotherapy re-plan
  time frame: 1 year
  description: Measured by retrospective assessment of dose accumulation of the CTVs
  arm group label: A
  description: Minimum of 12 patients who required total radiotherapy replan
  arm group label: B
  description: Minimum of 28 patients who were reviewed in the multi-professional meeting but did not require full replan
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Kevin Chiu
  phone: 0203 826 2020
  email: k.chiu@nhs.net
  last name: Rishma Bhatti
  phone: 0203 826 2020
  email: mvccresearch.enh-tr@nhs.net
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Head and Neck Neoplasms
  sharing ipd: No