<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/NCT03789773</url>
  </required_header>
  <id_info>
    <org_study_id>0S-18-6</org_study_id>
    <secondary_id>NCI-2018-02994</secondary_id>
    <secondary_id>0S-18-6</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT03789773</nct_id>
  </id_info>
  <brief_title>Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy</brief_title>
  <official_title>Holographic Mm-wave Imaging in Radiation Oncology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies the quality of holographic mm-wave imaging in patients undergoing&#xD;
      radiation therapy. Holographic mm-wave imaging is a common type of imaging used in airport&#xD;
      body scanners that may be helpful in improving the efficiency and positioning of radiation&#xD;
      oncology patients and their overall experience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To obtain patient images in a clinical setting and assess their quality.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the registration agreement through a voxel-voxel distance-to-agreement metric.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial&#xD;
      computed tomography (CT) simulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Grant ended, no accrual&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2022</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Qualitative assessment of holographic image quality</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Qualitative assessment of image quality by study physicians according to the scoring of each image as: 1 = High Quality (A); 2= Acceptable Quality (B); 3 = Poor/Unacceptable Quality (C). Lower value (1) represents a better score than higher value (3). There are no subscales and or total scores. The quality scores of the images will be tabulated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Image registration agreement between mm-wave holographic images and a cone-beam computed tomography (CBCT)/optical surface image</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>The distribution of the percent of points in voxel-voxel analysis to agree to better than 2 mm will be tabulated</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Unspecified Adult Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Diagnostic (holographic mm-wave imaging)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial CT simulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Millimeter-Wave Holographic Imaging</intervention_name>
    <description>Undergo mm-wave holographic imaging</description>
    <arm_group_label>Diagnostic (holographic mm-wave imaging)</arm_group_label>
    <other_name>Holographic Millimeter-wave Imaging; Holographic mm-Wave Imaging; MMW Holographic Imaging; Millimeter-wave Imaging; MMW Imaging; MMW</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are scheduled to receive either an optical or CBCT imaging scan as part&#xD;
             of their treatment management.&#xD;
&#xD;
          -  The study will be open to English and Spanish speaking participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that are not scheduled for fluoroscopic or optical imaging as part of the&#xD;
             normal course of radiotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Reilly</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03789773
org study id: 0S-18-6
secondary id: NCI-2018-02994
secondary id: 0S-18-6
secondary id: P30CA014089
nct id: NCT03789773
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This trial studies the quality of holographic mm-wave imaging in patients undergoing
      radiation therapy. Holographic mm-wave imaging is a common type of imaging used in airport
      body scanners that may be helpful in improving the efficiency and positioning of radiation
      oncology patients and their overall experience.
PRIMARY OBJECTIVES:

      I. To obtain patient images in a clinical setting and assess their quality.

      SECONDARY OBJECTIVES:

      I. To assess the registration agreement through a voxel-voxel distance-to-agreement metric.

      OUTLINE:

      Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial
      computed tomography (CT) simulation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Qualitative assessment of holographic image quality
time frame: Up to 1 year
description: Qualitative assessment of image quality by study physicians according to the scoring of each image as: 1 = High Quality (A); 2= Acceptable Quality (B); 3 = Poor/Unacceptable Quality (C). Lower value (1) represents a better score than higher value (3). There are no subscales and or total scores. The quality scores of the images will be tabulated.
measure: Image registration agreement between mm-wave holographic images and a cone-beam computed tomography (CBCT)/optical surface image
time frame: Up to 1 year
description: The distribution of the percent of points in voxel-voxel analysis to agree to better than 2 mm will be tabulated
arm group label: Diagnostic (holographic mm-wave imaging)
arm group type: Experimental
description: Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial CT simulation.
intervention type: Device
intervention name: Millimeter-Wave Holographic Imaging
description: Undergo mm-wave holographic imaging
arm group label: Diagnostic (holographic mm-wave imaging)
other name: Holographic Millimeter-wave Imaging; Holographic mm-Wave Imaging; MMW Holographic Imaging; Millimeter-wave Imaging; MMW Imaging; MMW
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Reilly
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor