<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/NCT03799523</url>
  </required_header>
  <id_info>
    <org_study_id>CTMS# 18-0135</org_study_id>
    <secondary_id>18-769H</secondary_id>
    <nct_id>NCT03799523</nct_id>
  </id_info>
  <brief_title>Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy</brief_title>
  <official_title>Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</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 first goal of this project is to validate the superiority of semi-permanent marks used in&#xD;
      conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out&#xD;
      the use of permanent tattoos for the investigator's patients. The secondary goal of this&#xD;
      project is to validate the superiority of specialized light-based surface imaging for daily&#xD;
      radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such&#xD;
      as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for&#xD;
      breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses surface imaging for breast patients to standardize or normalize planning&#xD;
      position &amp; minimize variability of port films thus reducing systematic error. The primary&#xD;
      objective of this study is to demonstrate the superiority of using surface imaging to combine&#xD;
      an ideally gated treatment planning CT and verification images timed to the breathing cycle,&#xD;
      quantified as the total within-subject variation of the measured location relative to current&#xD;
      methods of radiation delivery not using this approach. The secondary objective is to&#xD;
      demonstrate the superiority of specialized light-based surface imaging for daily radiation&#xD;
      set-up without tattoos compared to standard-of-care methods with regard to the total&#xD;
      within-subject variation of the measured location determined by weekly port films during a&#xD;
      course of radiation for breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Study enrollment is temporarily halted for interim analysis to ensure adequate evaluable&#xD;
    subjects.&#xD;
  </why_stopped>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Position measurement from Port films.</measure>
    <time_frame>Once weekly for 3 weeks up to 5 weeks</time_frame>
    <description>Distance measured (centimeters) from the planned position of radiotherapy to the actual position of radiotherapy on weekly port films. Port films are x-rays of the treatment field which are done to ensure that the patient and the radiation machine are properly aligned to each other. Weekly port films will be obtained for the duration of radiation treatment, which will be from three to five weeks in length.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Subjects undergoing breast radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the time of CT simulation study participants will receive temporary skin markings to be covered in clear medical grade tape. Light-based surface imaging will be used to determine alignment between the patient and the radiation machine. Radiation treatment will proceed as standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Temporary skin markings</intervention_name>
    <description>To use temporary markings in lieu of localization tattoos.</description>
    <arm_group_label>Subjects undergoing breast radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surface imaging</intervention_name>
    <description>To use light-based surface imaging for patient positioning during radiation treatment.</description>
    <arm_group_label>Subjects undergoing breast radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Biologically female&#xD;
&#xD;
          -  Ability to provide informed written consent in either English or Spanish&#xD;
&#xD;
          -  Surgical pathology and staging scans must demonstrate Ductal carcinoma in situ (DCIS)&#xD;
             or invasive breast cancer, Stages 0, 1, 2, and 3&#xD;
&#xD;
          -  Patient will undergo adjuvant radiation therapy as a part of multimodality breast&#xD;
             cancer treatment with plans for tangent field radiation treatment with or without&#xD;
             loco-regional lymph node targeting, based on the clinical judgement of the treating&#xD;
             physician&#xD;
&#xD;
          -  Willingness to maintain temporary skin markings for a part of their of radiation&#xD;
             therapy duration&#xD;
&#xD;
          -  Absence of any conditions that may affect ability to have either tattoos or skin&#xD;
             markings, as discussed in Exclusion Criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Biologically non-female&#xD;
&#xD;
          -  Inability or unwillingness of subject to give written informed consent&#xD;
&#xD;
          -  Patients found at presentation to have very locally-advanced cancer (e.g. inflammatory&#xD;
             breast cancer) or metastatic breast cancer (Stage 4)&#xD;
&#xD;
          -  Patients that will be treated with a deep-inspiration breath hold technique (typically&#xD;
             younger patients being treated for left-sided tumors)&#xD;
&#xD;
          -  Current pregnancy, as this is a contraindication to receiving radiation therapy&#xD;
&#xD;
          -  History of prior radiotherapy to the chest wall or torso&#xD;
&#xD;
          -  Known allergy / sensitivity to standard medical marking tattoo ink (by design&#xD;
             non-toxic, low-allergy), skin marking paint, or medical tape (e.g. Tegaderm)&#xD;
&#xD;
          -  Active drug or alcohol use or dependence evidenced by patient record and/or&#xD;
             self-report that, in the opinion of the investigator, would interfere with adherence&#xD;
             to daily radiation therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Galvan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UT Health San Antonio Mays Cancer Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 21, 2023</last_update_submitted>
  <last_update_submitted_qc>January 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03799523
org study id: CTMS# 18-0135
secondary id: 18-769H
nct id: NCT03799523
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The first goal of this project is to validate the superiority of semi-permanent marks used in
      conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out
      the use of permanent tattoos for the investigator's patients. The secondary goal of this
      project is to validate the superiority of specialized light-based surface imaging for daily
      radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such
      as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for
      breast cancer.
This study uses surface imaging for breast patients to standardize or normalize planning
      position & minimize variability of port films thus reducing systematic error. The primary
      objective of this study is to demonstrate the superiority of using surface imaging to combine
      an ideally gated treatment planning CT and verification images timed to the breathing cycle,
      quantified as the total within-subject variation of the measured location relative to current
      methods of radiation delivery not using this approach. The secondary objective is to
      demonstrate the superiority of specialized light-based surface imaging for daily radiation
      set-up without tattoos compared to standard-of-care methods with regard to the total
      within-subject variation of the measured location determined by weekly port films during a
      course of radiation for breast cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Position measurement from Port films.
time frame: Once weekly for 3 weeks up to 5 weeks
description: Distance measured (centimeters) from the planned position of radiotherapy to the actual position of radiotherapy on weekly port films. Port films are x-rays of the treatment field which are done to ensure that the patient and the radiation machine are properly aligned to each other. Weekly port films will be obtained for the duration of radiation treatment, which will be from three to five weeks in length.
arm group label: Subjects undergoing breast radiotherapy
arm group type: Experimental
description: At the time of CT simulation study participants will receive temporary skin markings to be covered in clear medical grade tape. Light-based surface imaging will be used to determine alignment between the patient and the radiation machine. Radiation treatment will proceed as standard of care.
intervention type: Other
intervention name: Temporary skin markings
description: To use temporary markings in lieu of localization tattoos.
arm group label: Subjects undergoing breast radiotherapy
intervention type: Other
intervention name: Surface imaging
description: To use light-based surface imaging for patient positioning during radiation treatment.
arm group label: Subjects undergoing breast radiotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eva Galvan, MD
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided