<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/NCT02212964</url>
  </required_header>
  <id_info>
    <org_study_id>UWO105014</org_study_id>
    <nct_id>NCT02212964</nct_id>
  </id_info>
  <brief_title>Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*</brief_title>
  <official_title>Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Functional and Metabolic Mapping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>London Regional Cancer Program, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Functional and Metabolic Mapping</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using a multi-echo gradient echo sequence to calculate R2* and quantitative susceptibility&#xD;
      maps and well as susceptibility-weighted imaging post processing the investigators&#xD;
      hypothesize that the investigators would be able to distinguish between pseudoprogression and&#xD;
      true progression with the use of an easily implementable sequence on clinical MRI scanners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-treatment radiographic imaging change (PTRIC) is seen in approximately 50% of patients&#xD;
      who are treated for brain neoplasms using chemotherapy and radiotherapy. PTRIC can be&#xD;
      attributed to true disease progression or a form of benign radiographic enhancement, known in&#xD;
      literature as pseudoprogression. Of these patients, 50% of them have benign radiographic&#xD;
      enhancement that is usually spontaneously resolved and required no intervention. The other&#xD;
      50% require immediate medical intervention, or more aggressive treatment for true&#xD;
      progression. Currently standard medical practise is to administer a prophylactic treatment of&#xD;
      chemotherapy to all patients with PTRIC with a follow up scan 3-6 months after initial PTRIC&#xD;
      diagnosis, leading to up to 50% of patients receiving an unneeded dose of chemotherapy. The&#xD;
      investigators hope to take advantage of the differentiation in tissue types and&#xD;
      vascularization between true progression tumour and pseudoprogression to be able to identify&#xD;
      patients who would not need to be administered a prophylactic dose of chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disease Progression</measure>
    <time_frame>6 months</time_frame>
    <description>R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression</description>
  </primary_outcome>
  <enrollment type="Actual">18</enrollment>
  <condition>Radiation Injury</condition>
  <condition>Radiation Necrosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have had treatment for brain neoplasms treated with radiation and/or&#xD;
        chemotherapy who presents with post-treatment imaging changes on the MRI following&#xD;
        treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject must consent to participate.&#xD;
&#xD;
          2. The subject must be above the age of 18.&#xD;
&#xD;
          3. Patients must be classified as possible pseudoprogression or true progression&#xD;
&#xD;
          4. Patients scoring &gt;= 70 on the karnofsky performance status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any subject with contraindication to an MRI procedure as listed in the Magnetic&#xD;
             Resonance Environment Screening Questionnaire.&#xD;
&#xD;
          2. Any subject who may be unable to tolerate the MRI environment due to physical size&#xD;
             and/or known tendency to claustrophobia.&#xD;
&#xD;
          3. Any subject who does not expect to be available to attend the for the required study&#xD;
             MRI scans&#xD;
&#xD;
          4. Patients scoring &lt; 70 on the karnofsky performance status.&#xD;
&#xD;
          5. Attending radiation oncologist or neurologist determines patient is no longer able to&#xD;
             consent for themselves.&#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>Ravi S Menon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University, Canada</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Glenn Bauman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Western Ontario</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6G2J9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>March 30, 2016</last_update_submitted>
  <last_update_submitted_qc>March 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiation Injury</keyword>
  <keyword>Radiation Necrosis</keyword>
  <keyword>Ultra-high field MRI</keyword>
  <keyword>Susceptibility Weighted Imaging</keyword>
  <keyword>Post-treatment radiographic imaging change</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Necrosis</mesh_term>
    <mesh_term>Disease Susceptibility</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Radiation Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02212964
org study id: UWO105014
nct id: NCT02212964
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Using a multi-echo gradient echo sequence to calculate R2* and quantitative susceptibility
      maps and well as susceptibility-weighted imaging post processing the investigators
      hypothesize that the investigators would be able to distinguish between pseudoprogression and
      true progression with the use of an easily implementable sequence on clinical MRI scanners.
Post-treatment radiographic imaging change (PTRIC) is seen in approximately 50% of patients
      who are treated for brain neoplasms using chemotherapy and radiotherapy. PTRIC can be
      attributed to true disease progression or a form of benign radiographic enhancement, known in
      literature as pseudoprogression. Of these patients, 50% of them have benign radiographic
      enhancement that is usually spontaneously resolved and required no intervention. The other
      50% require immediate medical intervention, or more aggressive treatment for true
      progression. Currently standard medical practise is to administer a prophylactic treatment of
      chemotherapy to all patients with PTRIC with a follow up scan 3-6 months after initial PTRIC
      diagnosis, leading to up to 50% of patients receiving an unneeded dose of chemotherapy. The
      investigators hope to take advantage of the differentiation in tissue types and
      vascularization between true progression tumour and pseudoprogression to be able to identify
      patients who would not need to be administered a prophylactic dose of chemotherapy.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Disease Progression
time frame: 6 months
description: R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ravi S Menon, PhD
role: Principal Investigator
affiliation: Western University, Canada
last name: Glenn Bauman, MD
role: Principal Investigator
affiliation: Western University, Canada
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Necrosis
mesh term: Disease Susceptibility
mesh term: Body Weight
mesh term: Radiation Injuries