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/NCT05975619</url>
    </required_header>
    <id_info>
      <org_study_id>VAR-2023-03</org_study_id>
      <nct_id>NCT05975619</nct_id>
    </id_info>
    <brief_title>A Prospective Imaging Study of the Integrated TrueBeam-HyperSight CBCT System</brief_title>
    <official_title>A Prospective Imaging Study of Target Definition and Radiation Planning Workflows on the Integrated TrueBeam-HyperSight System for Patients Receiving Radiation Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Varian, a Siemens Healthineers Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Varian, a Siemens Healthineers Company</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cone beam computed tomography (CBCT) images are routinely used in radiation treatment&#xD;
        delivery workflows to align patients with the treatment beam. Conventional CBCT image quality&#xD;
        is sufficient for this task but not good enough for other radiotherapy-related tasks, such as&#xD;
        contouring anatomical structures and calculating radiation dose distributions. HyperSight is&#xD;
        a new CBCT imaging system manufactured by Varian Medical Systems. The purpose of this study&#xD;
        is to evaluate the integration of the HyperSight imaging system with Varian's TrueBeam&#xD;
        radiotherapy system, a linear accelerator with a C-arm gantry that rotates about the patient&#xD;
        to delivery radiation to the target malignancy. HyperSight CBCT images will be acquired&#xD;
        prospectively from patients who are receiving radiation treatment. The HyperSight/TrueBeam&#xD;
        system will be used for imaging only; patients receive their radiation treatment on cleared&#xD;
        devices and no aspect of their treatment is affected by participation in the study.&#xD;
        HyperSight images collected during the study will be evaluated for quality and utility and&#xD;
        compared to conventional CBCT images as well as fan beam CT images used for treatment&#xD;
        planning.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">July 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>
      <intervention_model_description>This is a prospective, single-arm, single-site feasibility study designed to generate data describing the quality and applicability of on-couch high-performance CBCT imaging technology.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of using HyperSight CBCT images for radiation treatment planning.</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>The percentage of images that are of sufficient quality for patient treatment plan generation.</description>
    </primary_outcome>
    <other_outcome>
      <measure>OAR delineation</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Comparison of organ at risk (OAR) delineation on TrueBeam-HyperSight CBCT images to OAR delineation on conventional CBCT images, as well as on fan beam CT.</description>
    </other_outcome>
    <other_outcome>
      <measure>Image quality - quantitative</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Assessed through calculated image metrics.</description>
    </other_outcome>
    <other_outcome>
      <measure>Image quality - qualitative</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Assessed through expert observer evaluations of the images for utility in the radiotherapy workflow.</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient anxiety</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Assessed through a patient survey using the validated Six-Item State Anxiety Scale derived from the State-Trait Anxiety Inventory. Each of the six items in the survey are assigned a score from 1 to 4 indicating the patient's agreement to a statement such as &quot;I am tense&quot;, where 1 represents &quot;Not at all&quot;, and 4 represents &quot;Very much so&quot;.</description>
    </other_outcome>
    <other_outcome>
      <measure>Treatment plan quality</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Assessed through comparison of dose-volume histogram (DVH) metrics extracted from the re-calculation of the patient's treatment plan on the HyperSight CBCT to DVH metrics from the patient's treatment plan originally calculated on the pre-treatment simulation fan-beam CT.</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient clearance</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Evaluated by the number of instances where patient positioning and/or custom immobilization devices created for their standard-of-care radiation therapy were incompatible with system geometries of the TrueBeam-HyperSight system during imaging and clearance checks.</description>
    </other_outcome>
    <other_outcome>
      <measure>Timing of image registration</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>The time required to register a HyperSight CBCT to the patient's reference CT simulation image.</description>
    </other_outcome>
    <other_outcome>
      <measure>Confidence in image registration</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Assessed through a user-rated confidence (measured using a three-point scale: low/moderate/high).</description>
    </other_outcome>
    <other_outcome>
      <measure>Impact of off-axis imaging on Hounsfield Unit accuracy</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>In images where the center of rotation is shifted, the impact of the off-axis imaging on the HU accuracy will be evaluated by comparing dose-volume histogram metrics between the treatment plan generated on the off-axis HyperSight CBCT and DVH metrics from the patient's treatment plan, calculated on a fan-beam CT that does not have the same limited field of view as the CBCT.</description>
    </other_outcome>
    <other_outcome>
      <measure>Impact of image acquisition time on clinical efficiency</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Timing of workflow steps and processes including setup, imaging, alignment, and door-to-door time as compared to standard-of-care imaging processes, and compared to clinical models for hypothetical, generic clinics, using a time-driven, activity-based cost model.</description>
    </other_outcome>
    <other_outcome>
      <measure>Feasibility of obtaining respiratory gated HyperSight CBCT</measure>
      <time_frame>1-9 weeks</time_frame>
      <description>Assessed through evaluation of internal motion volumes of organs-at-risk and targets, relative to diaphragm and/or vertebral body position, as compared to 4D-CT from standard-of-care simulation imaging.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Head and Neck Cancer</condition>
    <condition>Thoracic Cancer</condition>
    <condition>Abdominal Cancer</condition>
    <condition>Pelvic Cancer</condition>
    <arm_group>
      <arm_group_label>HyperSight Imaging arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects are imaged with the new HyperSight CBCT imaging system.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>HyperSight imaging</intervention_name>
      <description>Subjects are scheduled for 1 to 5 HyperSight imaging sessions, which will occur on the same days as their standard clinical visits during planning and treatment delivery. A total of 5 to 10 HyperSight CBCT images will be acquired over all imaging sessions.</description>
      <arm_group_label>HyperSight Imaging arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient is scheduled to receive radiation therapy to one of the following anatomical&#xD;
               sites: head and neck/brain, thorax, abdomen, pelvis.&#xD;
  &#xD;
            2. Patient is at least 18 years of age.&#xD;
  &#xD;
            3. If the patient will be receiving IV contrast on study, patient must have adequate&#xD;
               renal function as defined by an estimated glomerular filtration rate (eGFR) of &gt;30.&#xD;
  &#xD;
               Note: if no IV contrast will be administered on study, patient may enroll without&#xD;
               creatinine level documented. Contrast eligibility will be determined as per Appendix&#xD;
               A.&#xD;
  &#xD;
            4. If the patient is a woman of childbearing potential, patient must have a negative&#xD;
               pregnancy test within 30 days of enrollment and prior to any study imaging.&#xD;
               Contraceptive use is not an adequate documentation of no chance of pregnancy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient is unwilling or unable to sign an IRB-approved written informed consent&#xD;
               document.&#xD;
  &#xD;
            2. Patient is part of a vulnerable population (per ISO 14155:2020, &quot;individuals who are&#xD;
               unable to fully understand all aspects of the investigation that are relevant to the&#xD;
               decision to participate, or who could be manipulated or unduly influenced as a result&#xD;
               of a compromised position, expectation of benefits or fear of retaliatory response&quot;).&#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_contact>
      <last_name>Sean Davidson</last_name>
      <phone>437-991-8294</phone>
      <email>sean.davidson@varian.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospitals Cleveland Medical Center</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lauren Henke, MD</last_name>
        <phone>800-641-2422</phone>
        <email>CTUReferral@UHhospitals.org</email>
      </contact>
      <investigator>
        <last_name>Lauren Henke, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Pelvic 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/NCT05975619
  org study id: VAR-2023-03
  nct id: NCT05975619
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  Cone beam computed tomography (CBCT) images are routinely used in radiation treatment
        delivery workflows to align patients with the treatment beam. Conventional CBCT image quality
        is sufficient for this task but not good enough for other radiotherapy-related tasks, such as
        contouring anatomical structures and calculating radiation dose distributions. HyperSight is
        a new CBCT imaging system manufactured by Varian Medical Systems. The purpose of this study
        is to evaluate the integration of the HyperSight imaging system with Varian's TrueBeam
        radiotherapy system, a linear accelerator with a C-arm gantry that rotates about the patient
        to delivery radiation to the target malignancy. HyperSight CBCT images will be acquired
        prospectively from patients who are receiving radiation treatment. The HyperSight/TrueBeam
        system will be used for imaging only; patients receive their radiation treatment on cleared
        devices and no aspect of their treatment is affected by participation in the study.
        HyperSight images collected during the study will be evaluated for quality and utility and
        compared to conventional CBCT images as well as fan beam CT images used for treatment
        planning.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This is a prospective, single-arm, single-site feasibility study designed to generate data describing the quality and applicability of on-couch high-performance CBCT imaging technology.
  primary purpose: Other
  masking: None (Open Label)
  measure: Feasibility of using HyperSight CBCT images for radiation treatment planning.
  time frame: 1-9 weeks
  description: The percentage of images that are of sufficient quality for patient treatment plan generation.
  measure: OAR delineation
  time frame: 1-9 weeks
  description: Comparison of organ at risk (OAR) delineation on TrueBeam-HyperSight CBCT images to OAR delineation on conventional CBCT images, as well as on fan beam CT.
  measure: Image quality - quantitative
  time frame: 1-9 weeks
  description: Assessed through calculated image metrics.
  measure: Image quality - qualitative
  time frame: 1-9 weeks
  description: Assessed through expert observer evaluations of the images for utility in the radiotherapy workflow.
  measure: Patient anxiety
  time frame: 1-9 weeks
  description: Assessed through a patient survey using the validated Six-Item State Anxiety Scale derived from the State-Trait Anxiety Inventory. Each of the six items in the survey are assigned a score from 1 to 4 indicating the patient's agreement to a statement such as "I am tense", where 1 represents "Not at all", and 4 represents "Very much so".
  measure: Treatment plan quality
  time frame: 1-9 weeks
  description: Assessed through comparison of dose-volume histogram (DVH) metrics extracted from the re-calculation of the patient's treatment plan on the HyperSight CBCT to DVH metrics from the patient's treatment plan originally calculated on the pre-treatment simulation fan-beam CT.
  measure: Patient clearance
  time frame: 1-9 weeks
  description: Evaluated by the number of instances where patient positioning and/or custom immobilization devices created for their standard-of-care radiation therapy were incompatible with system geometries of the TrueBeam-HyperSight system during imaging and clearance checks.
  measure: Timing of image registration
  time frame: 1-9 weeks
  description: The time required to register a HyperSight CBCT to the patient's reference CT simulation image.
  measure: Confidence in image registration
  time frame: 1-9 weeks
  description: Assessed through a user-rated confidence (measured using a three-point scale: low/moderate/high).
  measure: Impact of off-axis imaging on Hounsfield Unit accuracy
  time frame: 1-9 weeks
  description: In images where the center of rotation is shifted, the impact of the off-axis imaging on the HU accuracy will be evaluated by comparing dose-volume histogram metrics between the treatment plan generated on the off-axis HyperSight CBCT and DVH metrics from the patient's treatment plan, calculated on a fan-beam CT that does not have the same limited field of view as the CBCT.
  measure: Impact of image acquisition time on clinical efficiency
  time frame: 1-9 weeks
  description: Timing of workflow steps and processes including setup, imaging, alignment, and door-to-door time as compared to standard-of-care imaging processes, and compared to clinical models for hypothetical, generic clinics, using a time-driven, activity-based cost model.
  measure: Feasibility of obtaining respiratory gated HyperSight CBCT
  time frame: 1-9 weeks
  description: Assessed through evaluation of internal motion volumes of organs-at-risk and targets, relative to diaphragm and/or vertebral body position, as compared to 4D-CT from standard-of-care simulation imaging.
  arm group label: HyperSight Imaging arm
  arm group type: Experimental
  description: Subjects are imaged with the new HyperSight CBCT imaging system.
  intervention type: Device
  intervention name: HyperSight imaging
  description: Subjects are scheduled for 1 to 5 HyperSight imaging sessions, which will occur on the same days as their standard clinical visits during planning and treatment delivery. A total of 5 to 10 HyperSight CBCT images will be acquired over all imaging sessions.
  arm group label: HyperSight Imaging arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sean Davidson
  phone: 437-991-8294
  email: sean.davidson@varian.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Pelvic Neoplasms
  sharing ipd: No