<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/NCT03277469</url>
  </required_header>
  <id_info>
    <org_study_id>17-128</org_study_id>
    <nct_id>NCT03277469</nct_id>
  </id_info>
  <brief_title>Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer</brief_title>
  <official_title>Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that&#xD;
      will improve the brachytherapy procedure and treatment for participants with gynecologic&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is designed to develop new technology using MR imaging to improve the&#xD;
      brachytherapy procedure for participants with gynecologic cancer. The brachytherapy procedure&#xD;
      will take place in an MRI procedure room within the Advanced Multimodality Image-Guided&#xD;
      Operating (AMIGO) suite at Brigham and Women's Hospital. The purpose of the study will be to&#xD;
      evaluate whether the use of an MR-tracking device will improve the placement of the&#xD;
      brachytherapy catheters. This information will also be used to develop new software for&#xD;
      real-time brachytherapy planning by our physics team. The investigators believe that the&#xD;
      development of an MR-tracking device will allow them to better place the brachytherapy&#xD;
      catheters for radiation treatment and ultimately improve outcomes for patients, including&#xD;
      better local tumor control and a lower risk of side effects. The investigators will also&#xD;
      evaluate new MRI protocols to better define the tumor at the time of brachytherapy. The&#xD;
      brachytherapy treatment planning and delivery will follow standard of care.&#xD;
&#xD;
      In the past, brachytherapy treatment planning and delivery for gynecologic cancer was based&#xD;
      on plain-film X-rays, which did not account for the shape of the tumor, the unique anatomy of&#xD;
      an individual patient or the response to pelvic radiation therapy. In the last decade,&#xD;
      advances in technology have made it possible to perform the brachytherapy procedure and to&#xD;
      plan the delivered radiation dose based on CT or MR imaging. The use of CT or MR imaging for&#xD;
      brachytherapy planning is increasingly common in the United States, and has been shown to&#xD;
      result in improved tumor controls rates and a lower risk of radiation complications. The use&#xD;
      of MRI-guidance during the brachytherapy procedure is unique and this study will contribute&#xD;
      the advancement of this important technology. About half of the participants in this study&#xD;
      will be selected to have the MRI-guided brachytherapy procedure with the use of an&#xD;
      MRI-tracking device. This device will provide real-time positioning information of the&#xD;
      individual brachytherapy catheters while they are being placed and adjusted within the tumor.&#xD;
      The MR-tracker will also be used to develop new software that will allow our physics team to&#xD;
      generate a near-instantaneous brachytherapy plan as individual catheters are placed during&#xD;
      the procedure. The investigators hope that these advances in technology will have a&#xD;
      meaningful impact on further increasing tumor control and limiting the complication risk for&#xD;
      our participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Anticipated">September 15, 2027</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brachytherapy treatment parameters, including V150</measure>
    <time_frame>3 weeks</time_frame>
    <description>Comparison of brachytherapy treatment parameters for patients treated with or without use of an MR-tracker. V150 is the tumor volume that receives at least 150% of the prescribed radiation dose and is a measure of radiation dose heterogeneity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local-Failure-Free Survival</measure>
    <time_frame>Baseline to 2 years, 5 years</time_frame>
    <description>Time from diagnosis or recurrence to time of local failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Baseline to 2 years, 5 years</time_frame>
    <description>Time from diagnosis or recurrence to time of documented progression or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Baseline to 2 years, 5 years</time_frame>
    <description>Time from diagnosis or recurrence to time of death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Gynecologic Cancer</condition>
  <arm_group>
    <arm_group_label>MRI Guided BRACHYTHERAPY with Tracker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard pelvic MRI sequences will be obtained&#xD;
MRI Tracker is used during catheter positioning with serial MR imaging during implant&#xD;
All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice&#xD;
The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MRI Guided BRACHYTHERAPY without Tracker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard pelvic MRI sequences will be obtained&#xD;
Standard process is used with serial MR imaging to evaluate catheter position during implant&#xD;
All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice&#xD;
The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body</description>
    <arm_group_label>MRI Guided BRACHYTHERAPY with Tracker</arm_group_label>
    <arm_group_label>MRI Guided BRACHYTHERAPY without Tracker</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Brachytherapy</intervention_name>
    <description>Radiation therapy that is delivered by inserting radioactive sources directly into a tumor</description>
    <arm_group_label>MRI Guided BRACHYTHERAPY with Tracker</arm_group_label>
    <arm_group_label>MRI Guided BRACHYTHERAPY without Tracker</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI Tracker</intervention_name>
    <description>The MR tracking device consists of a series of radiofrequency (RF) microcoils that are embedded into brachytherapy catheter stylet. The RF microcoils allows for accurate spatial localization of an individual brachytherapy catheter.</description>
    <arm_group_label>MRI Guided BRACHYTHERAPY with Tracker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
             Subject is willing and able to comply with the protocol for the duration of the study&#xD;
             including undergoing treatment and scheduled visits and examinations including follow&#xD;
             up.&#xD;
&#xD;
          -  Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic&#xD;
             cancer for which intracavitary or interstitial brachytherapy is planned as standard&#xD;
             treatment. Eligible disease sites include primary or recurrent cancer of endometrial,&#xD;
             ovarian, cervical, vaginal, or vulvar origin.&#xD;
&#xD;
          -  Age of 18 years or older are eligible.&#xD;
&#xD;
          -  ECOG performance status of 2 or less.&#xD;
&#xD;
          -  Patients who have received prior radiation or chemotherapy may be enrolled on this&#xD;
             study.&#xD;
&#xD;
          -  Participant is deemed to be an appropriate candidate for MRI-guided brachytherapy by&#xD;
             the radiation oncologist and the patient elects to be treated with MRI-guided&#xD;
             brachytherapy.&#xD;
&#xD;
          -  Participant provides informed consent for prospective collection of relevant medical&#xD;
             records for analysis of clinical outcome and treatment-planning techniques.&#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, uncontrolled hypertension, interstitial lung disease, active peptic ulcer&#xD;
             disease or gastritis, active bleeding diatheses, serious chronic gastrointestinal&#xD;
             conditions associated with diarrhea or psychiatric illness/social situations that&#xD;
             would limit compliance with study requirements.&#xD;
&#xD;
          -  Contraindication to MRI identified by the MR procedure screening form, such as a&#xD;
             pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR&#xD;
             compatible implant or device.&#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>Martin King, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Martin King, MD, PhD</investigator_full_name>
    <investigator_title>Associate Professor of Radiation Oncology</investigator_title>
  </responsible_party>
  <keyword>Gynecologic Cancer</keyword>
  <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/NCT03277469
org study id: 17-128
nct id: NCT03277469
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that
      will improve the brachytherapy procedure and treatment for participants with gynecologic
      cancer.
This research study is designed to develop new technology using MR imaging to improve the
      brachytherapy procedure for participants with gynecologic cancer. The brachytherapy procedure
      will take place in an MRI procedure room within the Advanced Multimodality Image-Guided
      Operating (AMIGO) suite at Brigham and Women's Hospital. The purpose of the study will be to
      evaluate whether the use of an MR-tracking device will improve the placement of the
      brachytherapy catheters. This information will also be used to develop new software for
      real-time brachytherapy planning by our physics team. The investigators believe that the
      development of an MR-tracking device will allow them to better place the brachytherapy
      catheters for radiation treatment and ultimately improve outcomes for patients, including
      better local tumor control and a lower risk of side effects. The investigators will also
      evaluate new MRI protocols to better define the tumor at the time of brachytherapy. The
      brachytherapy treatment planning and delivery will follow standard of care.

      In the past, brachytherapy treatment planning and delivery for gynecologic cancer was based
      on plain-film X-rays, which did not account for the shape of the tumor, the unique anatomy of
      an individual patient or the response to pelvic radiation therapy. In the last decade,
      advances in technology have made it possible to perform the brachytherapy procedure and to
      plan the delivered radiation dose based on CT or MR imaging. The use of CT or MR imaging for
      brachytherapy planning is increasingly common in the United States, and has been shown to
      result in improved tumor controls rates and a lower risk of radiation complications. The use
      of MRI-guidance during the brachytherapy procedure is unique and this study will contribute
      the advancement of this important technology. About half of the participants in this study
      will be selected to have the MRI-guided brachytherapy procedure with the use of an
      MRI-tracking device. This device will provide real-time positioning information of the
      individual brachytherapy catheters while they are being placed and adjusted within the tumor.
      The MR-tracker will also be used to develop new software that will allow our physics team to
      generate a near-instantaneous brachytherapy plan as individual catheters are placed during
      the procedure. The investigators hope that these advances in technology will have a
      meaningful impact on further increasing tumor control and limiting the complication risk for
      our participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Brachytherapy treatment parameters, including V150
time frame: 3 weeks
description: Comparison of brachytherapy treatment parameters for patients treated with or without use of an MR-tracker. V150 is the tumor volume that receives at least 150% of the prescribed radiation dose and is a measure of radiation dose heterogeneity
measure: Local-Failure-Free Survival
time frame: Baseline to 2 years, 5 years
description: Time from diagnosis or recurrence to time of local failure
measure: Progression Free Survival
time frame: Baseline to 2 years, 5 years
description: Time from diagnosis or recurrence to time of documented progression or death
measure: Overall Survival
time frame: Baseline to 2 years, 5 years
description: Time from diagnosis or recurrence to time of death
arm group label: MRI Guided BRACHYTHERAPY with Tracker
arm group type: Experimental
description: Standard pelvic MRI sequences will be obtained
MRI Tracker is used during catheter positioning with serial MR imaging during implant
All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice
The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source
arm group label: MRI Guided BRACHYTHERAPY without Tracker
arm group type: Experimental
description: Standard pelvic MRI sequences will be obtained
Standard process is used with serial MR imaging to evaluate catheter position during implant
All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice
The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source
intervention type: Device
intervention name: MRI
description: Medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
arm group label: MRI Guided BRACHYTHERAPY with Tracker
arm group label: MRI Guided BRACHYTHERAPY without Tracker
intervention type: Radiation
intervention name: Brachytherapy
description: Radiation therapy that is delivered by inserting radioactive sources directly into a tumor
arm group label: MRI Guided BRACHYTHERAPY with Tracker
arm group label: MRI Guided BRACHYTHERAPY without Tracker
intervention type: Device
intervention name: MRI Tracker
description: The MR tracking device consists of a series of radiofrequency (RF) microcoils that are embedded into brachytherapy catheter stylet. The RF microcoils allows for accurate spatial localization of an individual brachytherapy catheter.
arm group label: MRI Guided BRACHYTHERAPY with Tracker
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin King, MD, PhD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Martin King, MD, PhD
investigator title: Associate Professor of Radiation Oncology
sharing ipd: No