<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/NCT02970474</url>
  </required_header>
  <id_info>
    <org_study_id>16-933857</org_study_id>
    <nct_id>NCT02970474</nct_id>
  </id_info>
  <brief_title>A Study Utilizing 3D Printing in Patients Undergoing External Beam Radiation Therapy</brief_title>
  <official_title>A Study Utilizing 3D Printing in Patients Undergoing External Beam Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tulane University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tulane University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some radiation therapy treatment plans require the use of boluses. Boluses are placed&#xD;
      directly on the skin overlying the area to be treated. The radiation beam interacts with the&#xD;
      bolus before entering the body and ensures that the correct radiation dose reaches your&#xD;
      tumor. The purpose of this study is to determine whether the shortcomings of conventional&#xD;
      bolus preparation can be overcome by using a 3D printer. CT scans of the body can be used to&#xD;
      create 3D models for boluses. The 3D models can then be printed into plastic boluses using a&#xD;
      3D printer. Preliminary studies have shown that 3D printed boluses conform to body contours&#xD;
      better and allow for more precise control over radiation dose. In this study, both a&#xD;
      conventional and 3D printed bolus will be made. The Investigators will then simulate&#xD;
      treatment with both boluses to determine which bolus will result in more optimal treatment&#xD;
      for the participant. The superior bolus will be used in the participant's treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In radiation therapy, high-energy radiation beams treat tumors by damaging cancer cells.&#xD;
      Treatment plans are designed with the goal of limiting exposure to adjacent healthy tissues.&#xD;
      Commonly used radiation beams demonstrate the &quot;skin-sparing effect&quot; which means that the&#xD;
      radiation dose builds up after the beam enters the skin and thus the maximum dose is reached&#xD;
      at some depth beneath the skin. For many tumors, this spares the skin from unnecessary&#xD;
      exposure while ensuring cancer cells beneath the skin receive the maximum dose. For cancers&#xD;
      that lie at or just below the skin surface, however, it is desirable for the maximum dose be&#xD;
      present at the skin surface. In such cases, a bolus (material with properties similar to&#xD;
      tissue) is used to mimic tissue and is placed above the skin. Dose build up occurs within the&#xD;
      bolus, thus allowing the maximum dose to be reached at the skin surface. Aside from the&#xD;
      treatment of superficial tumors, boluses have recently been used for modulated electron&#xD;
      radiation therapy (MERT). For MERT, the bolus thickness is varied so that the dose at a&#xD;
      specific depth can be varied at different locations within the tissue. With this technique,&#xD;
      the bolus is customized for a patient's specific anatomy and thus radiation exposure to&#xD;
      healthy tissue is minimized.&#xD;
&#xD;
      Boluses are typically made from moldable materials such as paraffin wax or superflab.&#xD;
      Conventional bolus preparation has its disadvantages; the patient is required to be present,&#xD;
      it can be time intensive and it is dependent on the skill of the fabricator. Furthermore, the&#xD;
      degree of conformity to the patient's skin is limited and, as a result, there can be&#xD;
      significant air gaps between the bolus and the patient's skin. Such air gaps have been shown&#xD;
      to create significant reduction in the surface dose.&#xD;
&#xD;
      The goal of the present study is to improve the current process of bolus preparation by&#xD;
      creating customized boluses with 3D printing. Customized boluses can be designed in Varian&#xD;
      eclipse software and then imported into 3D modeling software such as 3D Slicer. The 3D model&#xD;
      can then be converted into STL (Stereolithography) format which can be interpreted by the 3D&#xD;
      printer software. Several preliminary studies have reported success in creating such boluses.&#xD;
      One study reported good fit without air gaps (Kim) in their 3D printed bolus. Additionally,&#xD;
      several studies modeled tissue dose distributions for 3D printed boluses and found results&#xD;
      were similar to those obtained for conventional boluses.&#xD;
&#xD;
      For the current study, the Investigators will enroll participants who require boluses as part&#xD;
      of their treatment plan. Both a conventional and 3D bolus will be fabricated for each&#xD;
      participant. Computer simulation of dose distributions will be used to compare dosimetric&#xD;
      parameters. Additionally, air gaps for both boluses will be measured. For each participant,&#xD;
      the bolus that results in a more optimized dose distribution will be used for the&#xD;
      participant's actual treatment. Conducting the study will necessitate each enrolled&#xD;
      participant to undergo an additional CT scan to simulate treatment with the 3D printed bolus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of enrollment and loss of co-investigator.&#xD;
  </why_stopped>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Optimal radiation dose</measure>
    <time_frame>1 day</time_frame>
    <description>Boluses are used in radiation therapy to assure the optimal dose of radiation is applied to the tumor. Conventional boluses may have air gaps between the mold and the participants skin, or deform over time and use, which may make the dose of radiation change and not be at the optimal dose for the tumor. Therefore a 3D printed bolus will be molded based on a participant's CT images to construct a bolus to deliver the optimal dose of radiation to the tumor. Both boluses will be tested through a computer simulation to asses which bolus, conventional or 3D printed, provides the optimal radiation dose.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Radiotherapy</condition>
  <arm_group>
    <arm_group_label>All Participants</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants will undergo the same schedule. Each participant will be fitted with a conventional and a 3D printed bolus prior to receiving radiation therapy. Each bolus will be assessed for optimal dose distribution of the radiation to the tumor through computer stimulation. The bolus, either conventional or 3D printed, that is found to be superior will be used for the actual radiation therapy treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Bolus</intervention_name>
    <description>Conventional bolus is mold made from Super stuff powder, superflab, or paraffin wax and made to fit the contours of the body.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D Printed Bolus</intervention_name>
    <description>The 3D printed bolus is also made from Super stuff powder, superflab, or paraffin wax, however it uses CT scans to print a molded bolus from the images of the participant's body.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
          -  Requires bolus and is schedule for radiation therapy&#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>Steven DiBase, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tulane University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tulane University Cancer Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>January 11, 2018</last_update_submitted>
  <last_update_submitted_qc>January 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Currently there is no plan to share IPD.</ipd_description>
  </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/NCT02970474
org study id: 16-933857
nct id: NCT02970474
lead sponsor: 
has dmc: No
Some radiation therapy treatment plans require the use of boluses. Boluses are placed
      directly on the skin overlying the area to be treated. The radiation beam interacts with the
      bolus before entering the body and ensures that the correct radiation dose reaches your
      tumor. The purpose of this study is to determine whether the shortcomings of conventional
      bolus preparation can be overcome by using a 3D printer. CT scans of the body can be used to
      create 3D models for boluses. The 3D models can then be printed into plastic boluses using a
      3D printer. Preliminary studies have shown that 3D printed boluses conform to body contours
      better and allow for more precise control over radiation dose. In this study, both a
      conventional and 3D printed bolus will be made. The Investigators will then simulate
      treatment with both boluses to determine which bolus will result in more optimal treatment
      for the participant. The superior bolus will be used in the participant's treatment.
In radiation therapy, high-energy radiation beams treat tumors by damaging cancer cells.
      Treatment plans are designed with the goal of limiting exposure to adjacent healthy tissues.
      Commonly used radiation beams demonstrate the "skin-sparing effect" which means that the
      radiation dose builds up after the beam enters the skin and thus the maximum dose is reached
      at some depth beneath the skin. For many tumors, this spares the skin from unnecessary
      exposure while ensuring cancer cells beneath the skin receive the maximum dose. For cancers
      that lie at or just below the skin surface, however, it is desirable for the maximum dose be
      present at the skin surface. In such cases, a bolus (material with properties similar to
      tissue) is used to mimic tissue and is placed above the skin. Dose build up occurs within the
      bolus, thus allowing the maximum dose to be reached at the skin surface. Aside from the
      treatment of superficial tumors, boluses have recently been used for modulated electron
      radiation therapy (MERT). For MERT, the bolus thickness is varied so that the dose at a
      specific depth can be varied at different locations within the tissue. With this technique,
      the bolus is customized for a patient's specific anatomy and thus radiation exposure to
      healthy tissue is minimized.

      Boluses are typically made from moldable materials such as paraffin wax or superflab.
      Conventional bolus preparation has its disadvantages; the patient is required to be present,
      it can be time intensive and it is dependent on the skill of the fabricator. Furthermore, the
      degree of conformity to the patient's skin is limited and, as a result, there can be
      significant air gaps between the bolus and the patient's skin. Such air gaps have been shown
      to create significant reduction in the surface dose.

      The goal of the present study is to improve the current process of bolus preparation by
      creating customized boluses with 3D printing. Customized boluses can be designed in Varian
      eclipse software and then imported into 3D modeling software such as 3D Slicer. The 3D model
      can then be converted into STL (Stereolithography) format which can be interpreted by the 3D
      printer software. Several preliminary studies have reported success in creating such boluses.
      One study reported good fit without air gaps (Kim) in their 3D printed bolus. Additionally,
      several studies modeled tissue dose distributions for 3D printed boluses and found results
      were similar to those obtained for conventional boluses.

      For the current study, the Investigators will enroll participants who require boluses as part
      of their treatment plan. Both a conventional and 3D bolus will be fabricated for each
      participant. Computer simulation of dose distributions will be used to compare dosimetric
      parameters. Additionally, air gaps for both boluses will be measured. For each participant,
      the bolus that results in a more optimized dose distribution will be used for the
      participant's actual treatment. Conducting the study will necessitate each enrolled
      participant to undergo an additional CT scan to simulate treatment with the 3D printed bolus.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Optimal radiation dose
time frame: 1 day
description: Boluses are used in radiation therapy to assure the optimal dose of radiation is applied to the tumor. Conventional boluses may have air gaps between the mold and the participants skin, or deform over time and use, which may make the dose of radiation change and not be at the optimal dose for the tumor. Therefore a 3D printed bolus will be molded based on a participant's CT images to construct a bolus to deliver the optimal dose of radiation to the tumor. Both boluses will be tested through a computer simulation to asses which bolus, conventional or 3D printed, provides the optimal radiation dose.
arm group label: All Participants
arm group type: Other
description: All participants will undergo the same schedule. Each participant will be fitted with a conventional and a 3D printed bolus prior to receiving radiation therapy. Each bolus will be assessed for optimal dose distribution of the radiation to the tumor through computer stimulation. The bolus, either conventional or 3D printed, that is found to be superior will be used for the actual radiation therapy treatment.
intervention type: Device
intervention name: Conventional Bolus
description: Conventional bolus is mold made from Super stuff powder, superflab, or paraffin wax and made to fit the contours of the body.
arm group label: All Participants
intervention type: Device
intervention name: 3D Printed Bolus
description: The 3D printed bolus is also made from Super stuff powder, superflab, or paraffin wax, however it uses CT scans to print a molded bolus from the images of the participant's body.
arm group label: All Participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven DiBase, MD
role: Principal Investigator
affiliation: Tulane University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: Currently there is no plan to share IPD.