<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/NCT01703195</url>
  </required_header>
  <id_info>
    <org_study_id>2011-0656</org_study_id>
    <secondary_id>NCI-2012-02054</secondary_id>
    <nct_id>NCT01703195</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina</brief_title>
  <official_title>Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn if a type of MRI scan called diffusion&#xD;
      weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to&#xD;
      learn if DWI can predict how tumors will respond to radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If you agree to take part in this study, information will be collected from your medical&#xD;
      record including your age, sex, and status of the disease.&#xD;
&#xD;
      For the MRI scans, you will receive a routine contrast drug by vein. Contrast drugs are used&#xD;
      by doctors in order to see MRI images more clearly.&#xD;
&#xD;
      A modified MRI scan will performed right after your scheduled standard-of-care MRI scan. This&#xD;
      modified MRI scan is the investigational scan. To complete the modified MRI scan, you will&#xD;
      need to stay in the MRI scanner for about 8 extra minutes. It should take about 47 minutes&#xD;
      total to complete both scans.&#xD;
&#xD;
      The way that researchers program the MRI machine and the order in which the images are taken&#xD;
      is what is being modified for the investigational scan. These changes may help researchers&#xD;
      capture better images.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      Your participation on this study will be over after the modified MRI scan is complete.&#xD;
&#xD;
      This is an investigational study. The standard-of-care MRI scan method is FDA approved and&#xD;
      commercially available for the diagnosis of several diseases. The modified MRI scan method is&#xD;
      being used in research only.&#xD;
&#xD;
      Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">September 19, 2019</completion_date>
  <primary_completion_date type="Actual">September 19, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of Tumor Involvement Detection</measure>
    <time_frame>1 day</time_frame>
    <description>Location of tumor involvement determined based on pre-treatment imaging findings, where inferior margin of tumor marked on the MRI. Tumor involved areas will then be evaluated by EUA, where fiducial markers will be placed and MRI images will be fused with the CT images to find if there is any discrepancy between the EUA and the DWI images. The primary endpoint is the accuracy of tumor involvement detection (binary endpoint), where tumor invasion is defined as similar to that seen by EUA, in the anterior/posterior or the lateral walls of the vagina. Similarity will be defined as the tumor margin seen on MRI being similar to what is seen on the EUA where the markers correspond to the margins defined on the MRI. This will be defined as 5mm or less.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ability of Diffusion Weighted Magnetic Resonance Imaging (DWMR) to Assess Response to Radiation Therapy</measure>
    <time_frame>4 weeks after radiation therapy treatment</time_frame>
    <description>Secondary endpoints include quantitative measurements of discrepancies (or: quantitative measurement of the discrepancy) between DWMR and exam under anesthesia (EUA), agreement and difference between DWMR and other MR sequences (T2, DGE), and the ability of DWMR to assess response to therapy. Summary statistics of results for each modality tabulated. Accuracy, sensitivity, specificity, PPV, and NPV estimated along with corresponding 95% CIs. Quantitative discrepancy measurements summarized using mean, SD, and range. Difference and agreement between DWMR and other MR sequences assessed using the McNemar test and Kappa statistics, respectively.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Vaginal Cancer</condition>
  <arm_group>
    <arm_group_label>Diffusion Weighted Magnetic Resonance Imaging (DWMR)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients receive Magnetic Resonance Imaging (MRI) and Diffusion Weighted Magnetic Resonance Imaging (DWMR) imaging pre-treatment and 4-6 weeks post-treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>Magnetic Resonance Imaging (MRI) obtained pre-treatment and 4-6 weeks post-treatment.</description>
    <arm_group_label>Diffusion Weighted Magnetic Resonance Imaging (DWMR)</arm_group_label>
    <other_name>MRI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diffusion Weighted Magnetic Resonance Imaging (DWMR)</intervention_name>
    <description>Diffusion Weighted Magnetic Resonance Imaging (DWMR) obtained pre-treatment and 4-6 weeks post-treatment.</description>
    <arm_group_label>Diffusion Weighted Magnetic Resonance Imaging (DWMR)</arm_group_label>
    <other_name>DWMR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients who have gynecologic malignancies involving the middle third and the&#xD;
             distal third of the vagina who will be receiving radiation therapy&#xD;
&#xD;
          2. Patients who have gynecologic malignancies involving the upper, middle and/or lower&#xD;
             third of the vagina or are undergoing pelvic exenteration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant patients&#xD;
&#xD;
          2. Any implantable medical device that is not MRI compatible (e.g. pacemakers,&#xD;
             defibrillators, pain pumps or insulin pumps)&#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>Priya Bhosale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>September 20, 2019</last_update_submitted>
  <last_update_submitted_qc>September 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaginal Cancer</keyword>
  <keyword>Malignancies involving the vagina</keyword>
  <keyword>Middle third and the distal third of the vagina</keyword>
  <keyword>Pre and post radiation therapy</keyword>
  <keyword>Diffusion weighted magnetic resonance imaging</keyword>
  <keyword>DWMR</keyword>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>MRI</keyword>
  <keyword>Tumor involvement</keyword>
  <keyword>Response to radiation therapy</keyword>
  <keyword>XRT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Vaginal Neoplasms</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/NCT01703195
org study id: 2011-0656
secondary id: NCI-2012-02054
nct id: NCT01703195
lead sponsor: 
has dmc: No
The goal of this clinical research study is to learn if a type of MRI scan called diffusion
      weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to
      learn if DWI can predict how tumors will respond to radiation therapy.
If you agree to take part in this study, information will be collected from your medical
      record including your age, sex, and status of the disease.

      For the MRI scans, you will receive a routine contrast drug by vein. Contrast drugs are used
      by doctors in order to see MRI images more clearly.

      A modified MRI scan will performed right after your scheduled standard-of-care MRI scan. This
      modified MRI scan is the investigational scan. To complete the modified MRI scan, you will
      need to stay in the MRI scanner for about 8 extra minutes. It should take about 47 minutes
      total to complete both scans.

      The way that researchers program the MRI machine and the order in which the images are taken
      is what is being modified for the investigational scan. These changes may help researchers
      capture better images.

      Length of Study:

      Your participation on this study will be over after the modified MRI scan is complete.

      This is an investigational study. The standard-of-care MRI scan method is FDA approved and
      commercially available for the diagnosis of several diseases. The modified MRI scan method is
      being used in research only.

      Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy of Tumor Involvement Detection
time frame: 1 day
description: Location of tumor involvement determined based on pre-treatment imaging findings, where inferior margin of tumor marked on the MRI. Tumor involved areas will then be evaluated by EUA, where fiducial markers will be placed and MRI images will be fused with the CT images to find if there is any discrepancy between the EUA and the DWI images. The primary endpoint is the accuracy of tumor involvement detection (binary endpoint), where tumor invasion is defined as similar to that seen by EUA, in the anterior/posterior or the lateral walls of the vagina. Similarity will be defined as the tumor margin seen on MRI being similar to what is seen on the EUA where the markers correspond to the margins defined on the MRI. This will be defined as 5mm or less.
measure: Ability of Diffusion Weighted Magnetic Resonance Imaging (DWMR) to Assess Response to Radiation Therapy
time frame: 4 weeks after radiation therapy treatment
description: Secondary endpoints include quantitative measurements of discrepancies (or: quantitative measurement of the discrepancy) between DWMR and exam under anesthesia (EUA), agreement and difference between DWMR and other MR sequences (T2, DGE), and the ability of DWMR to assess response to therapy. Summary statistics of results for each modality tabulated. Accuracy, sensitivity, specificity, PPV, and NPV estimated along with corresponding 95% CIs. Quantitative discrepancy measurements summarized using mean, SD, and range. Difference and agreement between DWMR and other MR sequences assessed using the McNemar test and Kappa statistics, respectively.
arm group label: Diffusion Weighted Magnetic Resonance Imaging (DWMR)
arm group type: Other
description: Patients receive Magnetic Resonance Imaging (MRI) and Diffusion Weighted Magnetic Resonance Imaging (DWMR) imaging pre-treatment and 4-6 weeks post-treatment.
intervention type: Procedure
intervention name: Magnetic Resonance Imaging (MRI)
description: Magnetic Resonance Imaging (MRI) obtained pre-treatment and 4-6 weeks post-treatment.
arm group label: Diffusion Weighted Magnetic Resonance Imaging (DWMR)
other name: MRI
intervention type: Procedure
intervention name: Diffusion Weighted Magnetic Resonance Imaging (DWMR)
description: Diffusion Weighted Magnetic Resonance Imaging (DWMR) obtained pre-treatment and 4-6 weeks post-treatment.
arm group label: Diffusion Weighted Magnetic Resonance Imaging (DWMR)
other name: DWMR
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Priya Bhosale, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Vaginal Neoplasms