<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/NCT03297125</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00000087</org_study_id>
    <nct_id>NCT03297125</nct_id>
  </id_info>
  <brief_title>Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI</brief_title>
  <official_title>Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this prospective, nonrandomized controlled phase IV study is to compare&#xD;
      standard and advanced MRI for their ability to predict response to Optune therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol Summary: Optune therapy is a newly approved treatment for patients with&#xD;
      glioblastoma. This therapy demonstrated comparable outcomes for patients with recurrent GBM,&#xD;
      in comparison to standard therapies, but better quality of life. More recently, in an interim&#xD;
      analysis of 315 patients with GBM, adding Tumor Treating Fields (TTFields) to maintenance&#xD;
      temozolomide chemotherapy significantly prolonged progression-free and overall survival. It&#xD;
      also has demonstrated promise in other cancers such as pancreas, mesothelioma, ovarian and&#xD;
      lung. However, in order to optimize the treatment regimen, and potentially predict which&#xD;
      patients are most likely to respond, reliable ways of evaluation are necessary. Advanced&#xD;
      perfusion and diffusion MRI methods have shown utility with other treatments such as&#xD;
      bevacizumab. Preliminary data suggests the same might be true for the evaluation of Optune&#xD;
      therapy. The team therefore proposes to determine the utility of these methods to predict&#xD;
      response to Optune therapy. A successful result will have wide-ranging implications not only&#xD;
      for the optimization of Optune treatment of brain cancer but also other cancers shown to&#xD;
      benefit from this novel therapy.&#xD;
&#xD;
      Objective: To compare standard and advanced MRI for their ability to predict response to&#xD;
      Optune therapy. The team's approach will be to obtain both standard and advanced MRI in&#xD;
      patients with newly diagnosed glioblastoma undergoing adjuvant chemotherapy plus Optune&#xD;
      therapy. The ability of standard and advanced MRI to predict response will be assessed. The&#xD;
      hypothesis is that perfusion and/or diffusion imaging metrics can be used to predict response&#xD;
      to and elucidate mechanisms of action for Optune treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival.</measure>
    <time_frame>Six months.</time_frame>
    <description>The number of subjects alive at six months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival.</measure>
    <time_frame>One year.</time_frame>
    <description>The number of subjects alive at one year.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>Eligible Subjects</arm_group_label>
    <description>All enrolled subjects undergoing Optune therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>Standard MRI.</description>
    <arm_group_label>Eligible Subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Advanced MRI.</intervention_name>
    <description>Perfusion and diffusion MRI.</description>
    <arm_group_label>Eligible Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with newly diagnosed or recurrent glioblastoma who have self-selected Optune&#xD;
        therapy (group 1) or declined Optune therapy (group 2).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed glioblastoma (GBM), World Health Organization (WHO) grade IV.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Optune compliance &lt; 75%; they would be excluded from the final analyses.&#xD;
&#xD;
          -  History of craniectomy or significant skull defect (contraindication to Optune).&#xD;
&#xD;
          -  Active implantable medical device (e.g., deep brain stimulator (DBS), spinal cord&#xD;
             stimulator, pacemaker, defibrillator, vagus nerve stimulator, programmable shunt).&#xD;
&#xD;
          -  Karnofsky Performance Status (KPS) &lt; 60.&#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>Jennifer Connelly, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cathy Marszalkowski</last_name>
    <phone>414-955-1183</phone>
    <email>cmars@mcw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Froedtert Hospital &amp; Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Connelly, MD</last_name>
      <phone>414-805-5200</phone>
      <email>JConnelly@mcw.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Jennifer Connelly, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Optune Therapy</keyword>
  <keyword>MRI</keyword>
  <keyword>NovoCure-TTF-200A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</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/NCT03297125
org study id: PRO00000087
nct id: NCT03297125
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this prospective, nonrandomized controlled phase IV study is to compare
      standard and advanced MRI for their ability to predict response to Optune therapy.
Protocol Summary: Optune therapy is a newly approved treatment for patients with
      glioblastoma. This therapy demonstrated comparable outcomes for patients with recurrent GBM,
      in comparison to standard therapies, but better quality of life. More recently, in an interim
      analysis of 315 patients with GBM, adding Tumor Treating Fields (TTFields) to maintenance
      temozolomide chemotherapy significantly prolonged progression-free and overall survival. It
      also has demonstrated promise in other cancers such as pancreas, mesothelioma, ovarian and
      lung. However, in order to optimize the treatment regimen, and potentially predict which
      patients are most likely to respond, reliable ways of evaluation are necessary. Advanced
      perfusion and diffusion MRI methods have shown utility with other treatments such as
      bevacizumab. Preliminary data suggests the same might be true for the evaluation of Optune
      therapy. The team therefore proposes to determine the utility of these methods to predict
      response to Optune therapy. A successful result will have wide-ranging implications not only
      for the optimization of Optune treatment of brain cancer but also other cancers shown to
      benefit from this novel therapy.

      Objective: To compare standard and advanced MRI for their ability to predict response to
      Optune therapy. The team's approach will be to obtain both standard and advanced MRI in
      patients with newly diagnosed glioblastoma undergoing adjuvant chemotherapy plus Optune
      therapy. The ability of standard and advanced MRI to predict response will be assessed. The
      hypothesis is that perfusion and/or diffusion imaging metrics can be used to predict response
      to and elucidate mechanisms of action for Optune treatment.
observational model: Cohort
time perspective: Prospective
measure: Overall survival.
time frame: Six months.
description: The number of subjects alive at six months.
measure: Overall survival.
time frame: One year.
description: The number of subjects alive at one year.
arm group label: Eligible Subjects
description: All enrolled subjects undergoing Optune therapy.
intervention type: Device
intervention name: Standard Magnetic Resonance Imaging (MRI)
description: Standard MRI.
arm group label: Eligible Subjects
intervention type: Device
intervention name: Advanced MRI.
description: Perfusion and diffusion MRI.
arm group label: Eligible Subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Connelly, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Cathy Marszalkowski
phone: 414-955-1183
email: cmars@mcw.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Jennifer Connelly, MD
investigator title: Associate Professor
mesh term: Glioblastoma
sharing ipd: No