<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/NCT02993900</url>
  </required_header>
  <id_info>
    <org_study_id>J1660</org_study_id>
    <secondary_id>IRB00098525</secondary_id>
    <secondary_id>R21CA167800</secondary_id>
    <nct_id>NCT02993900</nct_id>
  </id_info>
  <brief_title>Image-Guided Gynecologic Brachytherapy</brief_title>
  <official_title>A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</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>
      This research is being done to evaluate multimodality imaging, including magnetic resonance&#xD;
      imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy&#xD;
      takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose&#xD;
      of this study is to investigate the ability of MRI to successfully guide the placement of the&#xD;
      brachytherapy applicator necessary to treat participants' gynecologic cancer. The&#xD;
      Investigators want to see if the use of MRI will do a better job of assessing the tumor at&#xD;
      the time of brachytherapy than the routinely used CT scan. The Investigators also want to&#xD;
      determine if the use of MRI will enable doctors to reduce the radiation dose received by the&#xD;
      body during the process of treating the tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this trial is to assess how magnetic resonance imaging (MRI) may be used to&#xD;
      improve tumor and normal tissue volume delineation, reducing toxicity and recurrence in&#xD;
      gynecologic brachytherapy. The Investigators will compare dosimetric values to the organs at&#xD;
      risk (OAR) with CT versus MRI planning. The Investigators anticipate that MR-planned cases&#xD;
      will have lower OAR doses than standard CT-based cases due to more conformal planning. The&#xD;
      Investigators will determine dose thresholds for radiation-related toxicity after treatment.&#xD;
      The Investigators will compare toxicity rates at 6 months, 1 and 2 years after treatment,&#xD;
      thereby enabling improved recommendations on dose limits to the OAR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 15, 2016</start_date>
  <completion_date type="Anticipated">December 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dosing changes</measure>
    <time_frame>3 years</time_frame>
    <description>To quantify the relative reduction of dose to rectum, sigmoid and bladder obtained after MR Simulator Suite-guided placement, as compared to standard CT guided treatment based on historical information and literature review.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of treatment-related toxicity</measure>
    <time_frame>3 months, 6 months and 1 year</time_frame>
    <description>To determine the rate of treatment-related toxicity within 3 months, 6 months and 1 year after MR Simulator Suite-guided placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to local failure</measure>
    <time_frame>1 year and 2 year</time_frame>
    <description>To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of survival</measure>
    <time_frame>1 year and 2 year</time_frame>
    <description>To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Uterine Cancer</condition>
  <condition>Vaginal Cancer</condition>
  <condition>Vulvar Cancer</condition>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Image-Guided Brachytherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Image-Guided Brachytherapy</intervention_name>
    <description>Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans</description>
    <arm_group_label>Image-Guided Brachytherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have histologically or cytologically confirmed carcinoma. Central&#xD;
             pathology review is not required; however, pathology will be reviewed at the SKCCC at&#xD;
             Johns Hopkins.&#xD;
&#xD;
          -  Site/Stage&#xD;
&#xD;
          -  Any patient eligible for internal implantation without MR guidance will be considered&#xD;
             eligible for this protocol. Standard criteria for internal implantation include:&#xD;
&#xD;
          -  Carcinoma of the cervix: Stage I-IVA or vaginal recurrence&#xD;
&#xD;
          -  Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal&#xD;
             recurrence&#xD;
&#xD;
          -  Carcinoma of the vagina: Stage I-IVA or vaginal recurrence&#xD;
&#xD;
          -  Carcinoma of the vulva: Stage I-IVA or recurrence&#xD;
&#xD;
          -  Carcinoma of the urethra based on treating physician's discretion&#xD;
&#xD;
          -  Patients who have received prior radiation or chemotherapy may be enrolled on this&#xD;
             study.&#xD;
&#xD;
          -  Age &gt; 18 years. Children do not develop these malignancies and therefore are not&#xD;
             considered candidates for this trial.&#xD;
&#xD;
          -  Life expectancy of greater than 6 months.&#xD;
&#xD;
          -  ECOG performance status of &lt;2 or greater, based on treating physician's discretion&#xD;
&#xD;
          -  MRI of the pelvis or PET-CT within 4 months before registration&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Absolute neutrophil count &lt; 500 at the time of enrollment&#xD;
&#xD;
          -  A history of metal in the head or eyes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akila Viswanathan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Department of Radiation Oncology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shirley DiPasquale, R.N.</last_name>
    <phone>410-614-1598</phone>
    <email>sdipasq1@jhmi.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The SKCCC at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shirl DiPasquale, R.N.</last_name>
      <phone>410-614-1598</phone>
      <email>sdipasq1@jhmi.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 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>Vulvar Neoplasms</mesh_term>
    <mesh_term>Vaginal Neoplasms</mesh_term>
    <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>


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/NCT02993900
org study id: J1660
secondary id: IRB00098525
secondary id: R21CA167800
nct id: NCT02993900
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research is being done to evaluate multimodality imaging, including magnetic resonance
      imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy
      takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose
      of this study is to investigate the ability of MRI to successfully guide the placement of the
      brachytherapy applicator necessary to treat participants' gynecologic cancer. The
      Investigators want to see if the use of MRI will do a better job of assessing the tumor at
      the time of brachytherapy than the routinely used CT scan. The Investigators also want to
      determine if the use of MRI will enable doctors to reduce the radiation dose received by the
      body during the process of treating the tumor.
The goal of this trial is to assess how magnetic resonance imaging (MRI) may be used to
      improve tumor and normal tissue volume delineation, reducing toxicity and recurrence in
      gynecologic brachytherapy. The Investigators will compare dosimetric values to the organs at
      risk (OAR) with CT versus MRI planning. The Investigators anticipate that MR-planned cases
      will have lower OAR doses than standard CT-based cases due to more conformal planning. The
      Investigators will determine dose thresholds for radiation-related toxicity after treatment.
      The Investigators will compare toxicity rates at 6 months, 1 and 2 years after treatment,
      thereby enabling improved recommendations on dose limits to the OAR.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dosing changes
time frame: 3 years
description: To quantify the relative reduction of dose to rectum, sigmoid and bladder obtained after MR Simulator Suite-guided placement, as compared to standard CT guided treatment based on historical information and literature review.
measure: The rate of treatment-related toxicity
time frame: 3 months, 6 months and 1 year
description: To determine the rate of treatment-related toxicity within 3 months, 6 months and 1 year after MR Simulator Suite-guided placement.
measure: Time to local failure
time frame: 1 year and 2 year
description: To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.
measure: Rate of survival
time frame: 1 year and 2 year
description: To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.
arm group label: Image-Guided Brachytherapy
arm group type: Experimental
description: Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy
intervention type: Device
intervention name: Image-Guided Brachytherapy
description: Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans
arm group label: Image-Guided Brachytherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Akila Viswanathan, M.D.
role: Principal Investigator
affiliation: Johns Hopkins Department of Radiation Oncology
last name: Shirley DiPasquale, R.N.
phone: 410-614-1598
email: sdipasq1@jhmi.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Vulvar Neoplasms
mesh term: Vaginal Neoplasms
mesh term: Uterine Neoplasms
sharing ipd: No