<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/NCT01671163</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201600243</org_study_id>
    <secondary_id>326-2012</secondary_id>
    <nct_id>NCT01671163</nct_id>
  </id_info>
  <brief_title>Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy</brief_title>
  <official_title>EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this research study is to evaluate placing the radiation therapy markers&#xD;
      (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic&#xD;
      Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the&#xD;
      end. The ultrasound will allow the doctor's to see where the radiation therapy markers&#xD;
      (Fiducial) is to be placed as outlined by the Radiation Oncologist.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient enrollment.&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 12, 2019</completion_date>
  <primary_completion_date type="Actual">August 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.</measure>
    <time_frame>approximately one week</time_frame>
    <description>The outcome measure for this study is to determine:&#xD;
The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system,&#xD;
The accuracy of the fiducial delivery into the targeted tissue and&#xD;
to see if the fiducials can be visualized via Endoscopic Ultrasound (EUS), Fluoroscopy and/or CT scan.&#xD;
The success and accuracy of the delivery will be evaluated by Endoscopic Ultrasound, fluoroscopy and/or CT scan to determine if the fiducials are in the targeted tissue. The subject's Oncologist will inform the endoscopist of the targeted tissue that is to receive the fiducials.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Subjects requiring fiducial placement</arm_group_label>
    <description>Endoscopic Ultrasound (EUS) for fiducial placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Ultrasound (EUS) for fiducial placement</intervention_name>
    <description>Endoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist</description>
    <arm_group_label>Subjects requiring fiducial placement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects who are currently scheduled to undergo fiducial placement at the University of&#xD;
        Florida in Gainesville as medically indicated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older,&#xD;
&#xD;
          -  Scheduled to undergo fiducial placement,&#xD;
&#xD;
          -  Subject must be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to performing endoscopy,&#xD;
&#xD;
          -  Participation in another research protocol that could interfere or influence the&#xD;
             outcomes measures of the present study,&#xD;
&#xD;
          -  The subject is unable/unwilling to give informed consent&#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>Peter V Draganov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Zlotecki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida/Shands</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Radiation therapy</keyword>
  <keyword>Fiducial markers</keyword>
  <!-- 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/NCT01671163
org study id: IRB201600243
secondary id: 326-2012
nct id: NCT01671163
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to evaluate placing the radiation therapy markers
      (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic
      Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the
      end. The ultrasound will allow the doctor's to see where the radiation therapy markers
      (Fiducial) is to be placed as outlined by the Radiation Oncologist.
observational model: Case-Only
time perspective: Prospective
measure: Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.
time frame: approximately one week
description: The outcome measure for this study is to determine:
The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system,
The accuracy of the fiducial delivery into the targeted tissue and
to see if the fiducials can be visualized via Endoscopic Ultrasound (EUS), Fluoroscopy and/or CT scan.
The success and accuracy of the delivery will be evaluated by Endoscopic Ultrasound, fluoroscopy and/or CT scan to determine if the fiducials are in the targeted tissue. The subject's Oncologist will inform the endoscopist of the targeted tissue that is to receive the fiducials.
arm group label: Subjects requiring fiducial placement
description: Endoscopic Ultrasound (EUS) for fiducial placement
intervention type: Procedure
intervention name: Endoscopic Ultrasound (EUS) for fiducial placement
description: Endoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist
arm group label: Subjects requiring fiducial placement
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter V Draganov, MD
role: Principal Investigator
affiliation: University of Florida
last name: Robert Zlotecki, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor