<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/NCT04488224</url>
  </required_header>
  <id_info>
    <org_study_id>Nano-X IG</org_study_id>
    <nct_id>NCT04488224</nct_id>
  </id_info>
  <brief_title>Nano-X Image Guidance: CBCT With Gravity-induced Motion</brief_title>
  <acronym>Nano-X IG</acronym>
  <official_title>Nano-X Image Guidance: CBCT With Gravity-induced Motion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sydney</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South Eastern Sydney Local Health District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sydney</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>
      A pilot stage, device feasibility trial, to investigate the feasibility of acquiring cone&#xD;
      beam computed tomography (CBCT) images for image guidance for radiation therapy by&#xD;
      maintaining a fixed imaging system and rotating the participant about the horizontal axis&#xD;
      using the Nano-X patient rotation system. It is a single-arm, controlled, single-blinded,&#xD;
      non-treatment, non-invasive, single-institution trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective:&#xD;
&#xD;
      To investigate the feasibility of volumetric image guidance for the Nano-X patient rotation&#xD;
      system (PRS).&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        1. To develop image reconstruction methods that allow target and normal tissue&#xD;
           visualisation at all treatment angles to a clinical cone beam computed tomography (CBCT)&#xD;
           standard.&#xD;
&#xD;
        2. To determine the reproducibility and variability in Nano-X CBCT compared to clinical&#xD;
           CBCT.&#xD;
&#xD;
        3. To measure the magnitude of gravity-induced anatomical deformation and translation.&#xD;
&#xD;
        4. To develop treatment plan adaptation methods to compensate for gravity-induced target&#xD;
           motion based on Nano-X CBCT image reconstruction at varying treatment angles.&#xD;
&#xD;
        5. To quantify the participant experience of horizontal rotation using the Nano-X PRS for&#xD;
           volumetric image guidance CBCT acquisition.&#xD;
&#xD;
      The investigators will perform a pilot stage, device feasibility trial, to investigate the&#xD;
      feasibility of acquiring CBCT images for image guidance by maintaining a fixed imaging system&#xD;
      and rotating the participant about the horizontal axis using the Nano-X PRS. It is a&#xD;
      single-arm, controlled, single-blinded, non-treatment, non-invasive, single-institution&#xD;
      trial.&#xD;
&#xD;
      Eligible participants will be asked to attend the Nelune Comprehensive Cancer Centre (NCCC)&#xD;
      at the Prince of Wales Hospital on two separate occasions to obtain Nano-X CBCT scans. For&#xD;
      each scan the participant will be rotated 360° about the horizontal axis which will take&#xD;
      approximately 72 seconds to complete.&#xD;
&#xD;
      Participants will be asked to complete validated psychometric questionnaires before and after&#xD;
      each Nano-X CBCT. The questionnaire responses will be used to quantify their experiences of&#xD;
      anxiety and motion sickness, and report previous experiences of claustrophobia, in order to&#xD;
      identify determinants of tolerance level.&#xD;
&#xD;
      The projection data sets from the Nano-X CBCT scans, along with conventional CBCTs obtained&#xD;
      for the participants' standard radiotherapy treatment, will be used to investigate the&#xD;
      image-related objectives. The two Nano-X CBCT data sets from each participant will be used to&#xD;
      compare Nano-X CBCT variability and reproducibility to clinical CBCT acquisition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2023</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All participants will undergo CBCT imaging during rotation on the Nano-X patient rotation system. For each participant, quality of CBCT images acquired during the rotation session will be compared with quality of CBCT images collected during their standard radiation therapy treatment.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The Postdoctoral Research Associate will collect and de-identify CBCT images acquired during Nano-X rotation session and during participants' routine treatment. The software used to display the scans will incorporate a random number generator to determine the labeling of images as 'A' or 'B'. Observers assessing image quality for study outcomes will be masked to the source of either image.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Cone Beam Computed Tomography (CBCT) images acquired with horizontal patient rotation that are deemed to be of comparable image quality to clinical CBCT or deemed acceptable for radiotherapy image guidance as scored by a panel of experts.</measure>
    <time_frame>6 months</time_frame>
    <description>Observers will view the image sets in 3 orthogonal views and grade the image quality considering geometrical accuracy, anatomical visualisation, sharpness of the image, soft tissue contrast, image noise and uniformity and overall clinical usability.&#xD;
The imaging method will be deemed technically feasible if &gt;70% of CBCT images acquired with horizontal patient rotation are deemed of clinical quality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Short Form State/Trait Anxiety inventory (STAI) and Fast Motion Sickness (FMS) questionnaire scores before and after rotation as assessed by the Wilcoxon signed rank test.</measure>
    <time_frame>6 months</time_frame>
    <description>Wilcoxon signed rank test used to determine statistically significant differences in anxiety and motion sickness assessed using psychometrically validated surveys completed prior to and post horizontal rotation CBCT scan.&#xD;
The STAI questionnaire is used to assess anxiety and is comprised of 6 questions scored 1-4. These are combined for a final score between 6 and 24, where a higher number indicates a greater level of anxiety.&#xD;
The FMS questionnaire is used to assess motion sickness. Participants rate their levels of motion sickness on a scale of 0-20 where 0 is no feeling of nausea and 20 is feeling terrible and very sick.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patients receiving CBCT Image Guidance during treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On two separate occasions, CBCT images will be acquired while participants are rotated 360° about the horizontal axis on the Nano-X Patient Rotation System. The rotation will take approximately 72 seconds to complete. Psychometrically validated questionnaires will be completed by the participant before and after each Nano-X CBCT session.&#xD;
Participants in this arm undergo conventional CBCT for image guidance during standard of care (SOC) radiotherapy treatment. These participants do not require an additional conventional CBCT as the SOC conventional CBCT images are used to benchmark the experimental Nano-X CBCT scans for evaluation of the primary outcome measure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients not receiving CBCT Image Guidance during treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On two separate occasions, CBCT images will be acquired while participants are rotated 360° about the horizontal axis on the Nano-X Patient Rotation System. The rotation will take approximately 72 seconds to complete. Psychometrically validated questionnaires will be completed by the participant before and after each Nano-X CBCT session.&#xD;
Participants in this arm do not undergo conventional CBCT for image guidance during standard of care (SOC) radiotherapy treatment. As such these participants will receive an additional conventional CBCT scan on standard equipment which used to benchmark the experimental NAno-X CBCT scans for evaluation of the primary outcome measure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nano-X Patient Rotation System</intervention_name>
    <description>The Nano-X prototype is a horizontal patient rotation system that immobilises participants while being rotated on the horizontal axis.&#xD;
This device will be used to rotate patients horizontally while cone-beam Computed Tomography (CBCT) projections are acquired.</description>
    <arm_group_label>Patients not receiving CBCT Image Guidance during treatment</arm_group_label>
    <arm_group_label>Patients receiving CBCT Image Guidance during treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Conventional CBCT scan</intervention_name>
    <description>A conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery.</description>
    <arm_group_label>Patients not receiving CBCT Image Guidance during treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychometrically validated questionnaires</intervention_name>
    <description>The Claustrophobia Questionnaire (CLQ), Short Form State/Trait Anxiety inventory (STAI) and Fast Motion Sickness (FMS) questionnaires administered. CLQ only once before the first session, STAI and FMS both before and after each Nano-X CBCT session.</description>
    <arm_group_label>Patients not receiving CBCT Image Guidance during treatment</arm_group_label>
    <arm_group_label>Patients receiving CBCT Image Guidance during treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cancer patients that are receiving radiation therapy that are able to be imaged with&#xD;
             the Nano-X PRS with one of the following tumour sites:&#xD;
&#xD;
               1. in the head/neck region&#xD;
&#xD;
               2. in the chest/abdomen/pelvic region with fast CBCT used for standard of care image&#xD;
                  guidance and is aged 60 years or older&#xD;
&#xD;
               3. in the chest/abdomen/pelvic region not receiving CBCT for standard of care image&#xD;
                  guidance and is aged 70 years or older&#xD;
&#xD;
               4. diagnosis of lung cancer with stage II-IV&#xD;
&#xD;
          2. ≥18 years of age&#xD;
&#xD;
          3. ECOG Performance Status 0-2&#xD;
&#xD;
          4. Must be able to communicate fluently in English to:&#xD;
&#xD;
             i. Receive instructions from operators of the PRS for safety entering and leaving the&#xD;
             Patient Rotation System and required conduct during the during the rotation session,&#xD;
             and ii. Communicate their level of comfort or distress to operators of the equipment.&#xD;
&#xD;
          5. Signed, written informed consent or approved alternative, non-contact method for&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women&#xD;
&#xD;
          2. Patients for whom attaining informed consent would not be possible, including mentally&#xD;
             impairment&#xD;
&#xD;
          3. Patients with severe vertigo or recent a diagnosis of Benign Paroxysmal Positioning&#xD;
             Vertigo.&#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>Paul J Keall, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ACRF Image X Institute, University of Sydney</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Jackson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prince of Wales Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Simon Downes, MASc</last_name>
    <role>Study Chair</role>
    <affiliation>Prince of Wales Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Gardner, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>ACRF Image X Institute, University of Sydney</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalie Plant, MHSc</last_name>
    <phone>+61 4 3483 4033</phone>
    <email>natalie.plant@sydney.edu.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shona Silvester</last_name>
    <email>shona.silvester@sydney.edu.au</email>
  </overall_contact_backup>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiation Therapy</keyword>
  <keyword>Image Guidance</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified study data may be provided to an external (non-university) research data repository, archive or register with the intention that it be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/board, under a materials transfer agreement with the university.</ipd_description>
    <ipd_time_frame>This data will become available upon completion of the study.</ipd_time_frame>
  </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/NCT04488224
org study id: Nano-X IG
nct id: NCT04488224
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A pilot stage, device feasibility trial, to investigate the feasibility of acquiring cone
      beam computed tomography (CBCT) images for image guidance for radiation therapy by
      maintaining a fixed imaging system and rotating the participant about the horizontal axis
      using the Nano-X patient rotation system. It is a single-arm, controlled, single-blinded,
      non-treatment, non-invasive, single-institution trial.
Primary objective:

      To investigate the feasibility of volumetric image guidance for the Nano-X patient rotation
      system (PRS).

      Secondary objectives:

        1. To develop image reconstruction methods that allow target and normal tissue
           visualisation at all treatment angles to a clinical cone beam computed tomography (CBCT)
           standard.

        2. To determine the reproducibility and variability in Nano-X CBCT compared to clinical
           CBCT.

        3. To measure the magnitude of gravity-induced anatomical deformation and translation.

        4. To develop treatment plan adaptation methods to compensate for gravity-induced target
           motion based on Nano-X CBCT image reconstruction at varying treatment angles.

        5. To quantify the participant experience of horizontal rotation using the Nano-X PRS for
           volumetric image guidance CBCT acquisition.

      The investigators will perform a pilot stage, device feasibility trial, to investigate the
      feasibility of acquiring CBCT images for image guidance by maintaining a fixed imaging system
      and rotating the participant about the horizontal axis using the Nano-X PRS. It is a
      single-arm, controlled, single-blinded, non-treatment, non-invasive, single-institution
      trial.

      Eligible participants will be asked to attend the Nelune Comprehensive Cancer Centre (NCCC)
      at the Prince of Wales Hospital on two separate occasions to obtain Nano-X CBCT scans. For
      each scan the participant will be rotated 360° about the horizontal axis which will take
      approximately 72 seconds to complete.

      Participants will be asked to complete validated psychometric questionnaires before and after
      each Nano-X CBCT. The questionnaire responses will be used to quantify their experiences of
      anxiety and motion sickness, and report previous experiences of claustrophobia, in order to
      identify determinants of tolerance level.

      The projection data sets from the Nano-X CBCT scans, along with conventional CBCTs obtained
      for the participants' standard radiotherapy treatment, will be used to investigate the
      image-related objectives. The two Nano-X CBCT data sets from each participant will be used to
      compare Nano-X CBCT variability and reproducibility to clinical CBCT acquisition.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: All participants will undergo CBCT imaging during rotation on the Nano-X patient rotation system. For each participant, quality of CBCT images acquired during the rotation session will be compared with quality of CBCT images collected during their standard radiation therapy treatment.
primary purpose: Device Feasibility
masking: Single (Outcomes Assessor)
masking description: The Postdoctoral Research Associate will collect and de-identify CBCT images acquired during Nano-X rotation session and during participants' routine treatment. The software used to display the scans will incorporate a random number generator to determine the labeling of images as 'A' or 'B'. Observers assessing image quality for study outcomes will be masked to the source of either image.
measure: Number of Cone Beam Computed Tomography (CBCT) images acquired with horizontal patient rotation that are deemed to be of comparable image quality to clinical CBCT or deemed acceptable for radiotherapy image guidance as scored by a panel of experts.
time frame: 6 months
description: Observers will view the image sets in 3 orthogonal views and grade the image quality considering geometrical accuracy, anatomical visualisation, sharpness of the image, soft tissue contrast, image noise and uniformity and overall clinical usability.
The imaging method will be deemed technically feasible if >70% of CBCT images acquired with horizontal patient rotation are deemed of clinical quality.
measure: Change in Short Form State/Trait Anxiety inventory (STAI) and Fast Motion Sickness (FMS) questionnaire scores before and after rotation as assessed by the Wilcoxon signed rank test.
time frame: 6 months
description: Wilcoxon signed rank test used to determine statistically significant differences in anxiety and motion sickness assessed using psychometrically validated surveys completed prior to and post horizontal rotation CBCT scan.
The STAI questionnaire is used to assess anxiety and is comprised of 6 questions scored 1-4. These are combined for a final score between 6 and 24, where a higher number indicates a greater level of anxiety.
The FMS questionnaire is used to assess motion sickness. Participants rate their levels of motion sickness on a scale of 0-20 where 0 is no feeling of nausea and 20 is feeling terrible and very sick.
arm group label: Patients receiving CBCT Image Guidance during treatment
arm group type: Experimental
description: On two separate occasions, CBCT images will be acquired while participants are rotated 360° about the horizontal axis on the Nano-X Patient Rotation System. The rotation will take approximately 72 seconds to complete. Psychometrically validated questionnaires will be completed by the participant before and after each Nano-X CBCT session.
Participants in this arm undergo conventional CBCT for image guidance during standard of care (SOC) radiotherapy treatment. These participants do not require an additional conventional CBCT as the SOC conventional CBCT images are used to benchmark the experimental Nano-X CBCT scans for evaluation of the primary outcome measure.
arm group label: Patients not receiving CBCT Image Guidance during treatment
arm group type: Experimental
description: On two separate occasions, CBCT images will be acquired while participants are rotated 360° about the horizontal axis on the Nano-X Patient Rotation System. The rotation will take approximately 72 seconds to complete. Psychometrically validated questionnaires will be completed by the participant before and after each Nano-X CBCT session.
Participants in this arm do not undergo conventional CBCT for image guidance during standard of care (SOC) radiotherapy treatment. As such these participants will receive an additional conventional CBCT scan on standard equipment which used to benchmark the experimental NAno-X CBCT scans for evaluation of the primary outcome measure.
intervention type: Device
intervention name: Nano-X Patient Rotation System
description: The Nano-X prototype is a horizontal patient rotation system that immobilises participants while being rotated on the horizontal axis.
This device will be used to rotate patients horizontally while cone-beam Computed Tomography (CBCT) projections are acquired.
arm group label: Patients not receiving CBCT Image Guidance during treatment
arm group label: Patients receiving CBCT Image Guidance during treatment
intervention type: Radiation
intervention name: Conventional CBCT scan
description: A conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery.
arm group label: Patients not receiving CBCT Image Guidance during treatment
intervention type: Other
intervention name: Psychometrically validated questionnaires
description: The Claustrophobia Questionnaire (CLQ), Short Form State/Trait Anxiety inventory (STAI) and Fast Motion Sickness (FMS) questionnaires administered. CLQ only once before the first session, STAI and FMS both before and after each Nano-X CBCT session.
arm group label: Patients not receiving CBCT Image Guidance during treatment
arm group label: Patients receiving CBCT Image Guidance during treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul J Keall, PhD
role: Principal Investigator
affiliation: ACRF Image X Institute, University of Sydney
last name: Michael Jackson, MD
role: Principal Investigator
affiliation: Prince of Wales Hospital
last name: Simon Downes, MASc
role: Study Chair
affiliation: Prince of Wales Hospital
last name: Mark Gardner, PhD
role: Study Chair
affiliation: ACRF Image X Institute, University of Sydney
last name: Natalie Plant, MHSc
phone: +61 4 3483 4033
email: natalie.plant@sydney.edu.au
last name: Shona Silvester
email: shona.silvester@sydney.edu.au
responsible party type: Sponsor
sharing ipd: Yes
ipd description: De-identified study data may be provided to an external (non-university) research data repository, archive or register with the intention that it be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/board, under a materials transfer agreement with the university.
ipd time frame: This data will become available upon completion of the study.