xml: <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/NCT05977621</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00113768</org_study_id>
      <nct_id>NCT05977621</nct_id>
    </id_info>
    <brief_title>Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking</brief_title>
    <acronym>(TRUS)</acronym>
    <official_title>Acquisition of Trans-Rectal Ultrasound [TRUS] Images of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking for Image-Guided Brachytherapy: A Pre-feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eigen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</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 study is to utilize transrectal ultrasound (TRUS) images of the intact&#xD;
        and post-hysterectomy female pelvis in order to provide feasibility information for a&#xD;
        Magnetic Resonance Imaging (MRI)-TRUS fusion based 3D needle navigation system for use in&#xD;
        image guided brachytherapy. The fusion and needle guidance will be performed using Eigen&#xD;
        Health's navigation system that currently provides targeted MR/Ultrasound fusion based&#xD;
        prostate biopsies utilizing a proprietary 3D semi-robotic navigation system.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Number of patients whose MRI and ultrasound images are fused</measure>
      <time_frame>up to 5 weeks</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">7</enrollment>
    <condition>Uterine Cancer</condition>
    <arm_group>
      <arm_group_label>Intact anatomy</arm_group_label>
      <description>Patients with intact anatomy (uterus and cervix)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Post-hysterectomy</arm_group_label>
      <description>Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Transrectal ultrasound (TRUS)</intervention_name>
      <description>Transrectal ultrasound (TRUS) images of the female pelvis</description>
      <arm_group_label>Intact anatomy</arm_group_label>
      <arm_group_label>Post-hysterectomy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who are undergoing brachytherapy as part of the standard plan for their&#xD;
          gynecologic cancer diagnosis (defined above) will be our target population. Only women will&#xD;
          be eligible for this study. Women of all races/ethnicities will be eligible, and accrual is&#xD;
          expected to reflect the population of patients seen in the Duke Radiation Oncology Clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically proven invasive primary squamous, adenosquamous, or adenocarcinoma of&#xD;
               the uterine cervix, (recurrent or medically inoperable) uterine adenocarcinoma.&#xD;
  &#xD;
            -  Treatment plan must include curative-intent definitive radiation that includes&#xD;
               brachytherapy treatments with or without concurrent chemotherapy&#xD;
  &#xD;
            -  Adults ≥ 18 years of age&#xD;
  &#xD;
            -  ECOG Performance Status 0-2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with active rectal bleeding or rectal ulcer&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dianda Ayala-Peacock, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University Health System (DUHS)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kaitlin Bailey, BNS RN</last_name>
      <phone>(919) 668-3726</phone>
      <email>Kaitlin.Bailey@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Joan Cahill, BNS OCN CCRP</last_name>
      <phone>(919) 668-5211</phone>
      <email>Joan.Cahill@duke.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Duke Cancer Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kaitlin Bailey, RN</last_name>
        <phone>919-668-3726</phone>
        <email>Kaitlin.Bailey@duke.edu</email>
      </contact>
      <contact_backup>
        <last_name>Joan Cahill, BSN OCN CCRP</last_name>
        <phone>(919) 668-5211</phone>
        <email>Joan.Cahill@duke.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Diandra Ayala-Peacock, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977621
  org study id: Pro00113768
  nct id: NCT05977621
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to utilize transrectal ultrasound (TRUS) images of the intact
        and post-hysterectomy female pelvis in order to provide feasibility information for a
        Magnetic Resonance Imaging (MRI)-TRUS fusion based 3D needle navigation system for use in
        image guided brachytherapy. The fusion and needle guidance will be performed using Eigen
        Health's navigation system that currently provides targeted MR/Ultrasound fusion based
        prostate biopsies utilizing a proprietary 3D semi-robotic navigation system.
  observational model: Case-Only
  time perspective: Prospective
  measure: Number of patients whose MRI and ultrasound images are fused
  time frame: up to 5 weeks
  arm group label: Intact anatomy
  description: Patients with intact anatomy (uterus and cervix)
  arm group label: Post-hysterectomy
  description: Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy
  intervention type: Other
  intervention name: Transrectal ultrasound (TRUS)
  description: Transrectal ultrasound (TRUS) images of the female pelvis
  arm group label: Intact anatomy
  arm group label: Post-hysterectomy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Dianda Ayala-Peacock, MD
  role: Principal Investigator
  affiliation: Duke University Health System (DUHS)
  last name: Kaitlin Bailey, BNS RN
  phone: (919) 668-3726
  email: Kaitlin.Bailey@duke.edu
  last name: Joan Cahill, BNS OCN CCRP
  phone: (919) 668-5211
  email: Joan.Cahill@duke.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Uterine Neoplasms
  sharing ipd: No