<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/NCT01706705</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0546</org_study_id>
    <secondary_id>NCI-2012-02120</secondary_id>
    <nct_id>NCT01706705</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study</brief_title>
  <official_title>3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator</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 computed tomography (CT) and magnetic&#xD;
      resonance imaging (MRI) images can better help to plan internal radiation treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment planning for patients with cervical cancer treated at MD Anderson is usually&#xD;
      performed based on x-ray films taken while the patient is under anesthesia in the operating&#xD;
      room. In this study, you will have an MRI and CT scan performed after recovering from&#xD;
      anesthesia in addition to the standard x-rays. In order to allow MRI images to be taken,&#xD;
      special MRI compatible applicators will be used. The CT and MRI images will be reviewed by&#xD;
      the doctor in charge of radiation treatment and will also be used for research purposes.&#xD;
&#xD;
      Study Procedures:&#xD;
&#xD;
      If you agree to take part in this study, an applicator made of a material that can be used&#xD;
      during an MRI will be used.&#xD;
&#xD;
      You will have a CT scan and an MRI scan performed after the implant is placed in the&#xD;
      operating room. The CT scan should take about 20 minutes and the MRI about 55 minutes. These&#xD;
      scans will be performed after you wake up from general anesthesia. Pain medicine will be&#xD;
      given if you feel any discomfort from the placement of the implant.&#xD;
&#xD;
      The additional scans will be used to confirm appropriate placement of the applicator and may&#xD;
      result in small adjustments to your radiation treatment plan.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      Your active participation on this study will be complete once you have the CT and MRI scans.&#xD;
&#xD;
      Your medical record may be reviewed after the scans for the purposes of the study, but you&#xD;
      will not be contacted in the future.&#xD;
&#xD;
      This is an investigational study. The applicator that best fits your personal anatomy will be&#xD;
      used in this study. A selection of MRI compatible applicators are available. Many of the MRI&#xD;
      applicators that will be used are FDA approved. However, in some cases you may have a novel&#xD;
      device with a moveable shield placed. This applicator is not FDA approved or commercially&#xD;
      available.&#xD;
&#xD;
      Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2012</start_date>
  <completion_date type="Actual">April 22, 2018</completion_date>
  <primary_completion_date type="Actual">April 22, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Improved Image Quality in the Shifted Position</measure>
    <time_frame>At the time of implant</time_frame>
    <description>To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the &quot;shifted&quot; position and in the &quot;standard&quot; position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position</measure>
    <time_frame>At the time of implant</time_frame>
    <description>The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the &quot;shifted&quot; position and in the &quot;standard&quot; position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer</measure>
    <time_frame>24 months from baseline</time_frame>
    <description>Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer</description>
  </other_outcome>
  <other_outcome>
    <measure>Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer&quot;.</measure>
    <time_frame>24 months from baseline ( 2-years)</time_frame>
    <description>Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing</measure>
    <time_frame>24 months from baseline ( 2-years)</time_frame>
    <description>MRI-based brachytherapy planning for patients with tumors &gt;5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI</description>
  </other_outcome>
  <other_outcome>
    <measure>Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.</measure>
    <time_frame>24 months from baseline ( 2-years)</time_frame>
    <description>RI-adaptive applicators for treatment planning for every case/patient.</description>
  </other_outcome>
  <other_outcome>
    <measure>Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.</measure>
    <time_frame>Not able to complete</time_frame>
    <description>Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Brachytherapy Treatment Planning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRI-compatible intracavitary applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.&#xD;
Computed tomography (CT) scan and a magnetic resonance imaging (MRI) scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 45 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intracavitary Applicator Placement</intervention_name>
    <description>MRI-compatible applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.</description>
    <arm_group_label>Brachytherapy Treatment Planning</arm_group_label>
    <other_name>MDA Applicator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computed Tomography (CT)</intervention_name>
    <description>CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.</description>
    <arm_group_label>Brachytherapy Treatment Planning</arm_group_label>
    <other_name>CT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.</description>
    <arm_group_label>Brachytherapy Treatment Planning</arm_group_label>
    <other_name>MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1) Women with stage greater than or equal to IB2 cervical cancer treated with definitive&#xD;
        chemoradiation or radiation therapy who require intracavitary brachytherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.&#xD;
&#xD;
          2. Patients who require interstitial brachytherapy.&#xD;
&#xD;
          3. Patients whose treating physician feels that they require additional 3D imaging at the&#xD;
             time of implant based on physical exam or initial findings.&#xD;
&#xD;
          4. Patients with implantable cardioverter-defibrillator, pacemaker or other implanted&#xD;
             device, which precludes MRI acquisition.&#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>Ann Klopp, 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>January 2022</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>September 3, 2019</results_first_submitted>
  <results_first_submitted_qc>January 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2022</results_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical Cancer</keyword>
  <keyword>Radiation therapy</keyword>
  <keyword>XRT</keyword>
  <keyword>External beam therapy</keyword>
  <keyword>Brachytherapy</keyword>
  <keyword>Intracavitary brachytherapy</keyword>
  <keyword>ICBT</keyword>
  <keyword>MRI compatible intracavitary applicators</keyword>
  <keyword>Computed tomography</keyword>
  <keyword>CT</keyword>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>MRI</keyword>
  <keyword>MRI compatible applicators</keyword>
  <keyword>3D image guided treatment planning</keyword>
  <keyword>2D treatment planning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 5, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT01706705/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental Brachytherapy Treatment Planning</title>
          <description>Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-clinical</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental Brachytherapy Treatment Planning</title>
          <description>Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" lower_limit="25" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Improved Image Quality in the Shifted Position</title>
        <description>To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the &quot;shifted&quot; position and in the &quot;standard&quot; position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.</description>
        <time_frame>At the time of implant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Brachytherapy Treatment Planning</title>
            <description>Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improved Image Quality in the Shifted Position</title>
          <description>To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the &quot;shifted&quot; position and in the &quot;standard&quot; position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standard Position</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shifted Position</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position</title>
        <description>The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the &quot;shifted&quot; position and in the &quot;standard&quot; position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.</description>
        <time_frame>At the time of implant</time_frame>
        <population>The adaptive applicator fit into 15 of the evaluated patients so the analysis was limited to these 15 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm-Study</title>
            <description>Experimental Brachytherapy Treatment Planning</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position</title>
          <description>The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the &quot;shifted&quot; position and in the &quot;standard&quot; position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.</description>
          <population>The adaptive applicator fit into 15 of the evaluated patients so the analysis was limited to these 15 patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adaptive Applicator in the Standard Position</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adaptive Applicator in the Shifted Position</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer</title>
        <description>Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer</description>
        <time_frame>24 months from baseline</time_frame>
        <population>No data collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm-Study</title>
            <description>Experimental Brachytherapy Treatment Planning</description>
          </group>
        </group_list>
        <measure>
          <title>3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer</title>
          <description>Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer</description>
          <population>No data collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer&quot;.</title>
        <description>Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.</description>
        <time_frame>24 months from baseline ( 2-years)</time_frame>
        <population>No data collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm-Study</title>
            <description>Experimental Brachytherapy Treatment Planning</description>
          </group>
        </group_list>
        <measure>
          <title>Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer&quot;.</title>
          <description>Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.</description>
          <population>No data collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing</title>
        <description>MRI-based brachytherapy planning for patients with tumors &gt;5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI</description>
        <time_frame>24 months from baseline ( 2-years)</time_frame>
        <population>No data collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm-Study</title>
            <description>Experimental Brachytherapy Treatment Planning</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing</title>
          <description>MRI-based brachytherapy planning for patients with tumors &gt;5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI</description>
          <population>No data collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.</title>
        <description>RI-adaptive applicators for treatment planning for every case/patient.</description>
        <time_frame>24 months from baseline ( 2-years)</time_frame>
        <population>No data collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm-Study</title>
            <description>Experimental Brachytherapy Treatment Planning</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.</title>
          <description>RI-adaptive applicators for treatment planning for every case/patient.</description>
          <population>No data collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.</title>
        <description>Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.</description>
        <time_frame>Not able to complete</time_frame>
        <population>Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm-Study</title>
            <description>Experimental Brachytherapy Treatment Planning</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.</title>
          <description>Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.</description>
          <population>Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>At the time of implant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental Brachytherapy Treatment Planning</title>
          <description>Single Arm study in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Ann Klopp / Associate Professor, Radiation Oncology</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>713-563-6930</phone>
      <email>aklopp@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01706705
org study id: 2012-0546
secondary id: NCI-2012-02120
nct id: NCT01706705
lead sponsor: 
has dmc: No
The goal of this clinical research study is to learn if computed tomography (CT) and magnetic
      resonance imaging (MRI) images can better help to plan internal radiation treatment.
Treatment planning for patients with cervical cancer treated at MD Anderson is usually
      performed based on x-ray films taken while the patient is under anesthesia in the operating
      room. In this study, you will have an MRI and CT scan performed after recovering from
      anesthesia in addition to the standard x-rays. In order to allow MRI images to be taken,
      special MRI compatible applicators will be used. The CT and MRI images will be reviewed by
      the doctor in charge of radiation treatment and will also be used for research purposes.

      Study Procedures:

      If you agree to take part in this study, an applicator made of a material that can be used
      during an MRI will be used.

      You will have a CT scan and an MRI scan performed after the implant is placed in the
      operating room. The CT scan should take about 20 minutes and the MRI about 55 minutes. These
      scans will be performed after you wake up from general anesthesia. Pain medicine will be
      given if you feel any discomfort from the placement of the implant.

      The additional scans will be used to confirm appropriate placement of the applicator and may
      result in small adjustments to your radiation treatment plan.

      Length of Study:

      Your active participation on this study will be complete once you have the CT and MRI scans.

      Your medical record may be reviewed after the scans for the purposes of the study, but you
      will not be contacted in the future.

      This is an investigational study. The applicator that best fits your personal anatomy will be
      used in this study. A selection of MRI compatible applicators are available. Many of the MRI
      applicators that will be used are FDA approved. However, in some cases you may have a novel
      device with a moveable shield placed. This applicator is not FDA approved or commercially
      available.

      Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants With Improved Image Quality in the Shifted Position
time frame: At the time of implant
description: To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the "shifted" position and in the "standard" position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.
measure: Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position
time frame: At the time of implant
description: The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the "shifted" position and in the "standard" position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.
measure: 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer
time frame: 24 months from baseline
description: Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer
measure: Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer".
time frame: 24 months from baseline ( 2-years)
description: Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.
measure: Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing
time frame: 24 months from baseline ( 2-years)
description: MRI-based brachytherapy planning for patients with tumors >5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI
measure: Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.
time frame: 24 months from baseline ( 2-years)
description: RI-adaptive applicators for treatment planning for every case/patient.
measure: Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.
time frame: Not able to complete
description: Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.
arm group label: Brachytherapy Treatment Planning
arm group type: Experimental
description: MRI-compatible intracavitary applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.
Computed tomography (CT) scan and a magnetic resonance imaging (MRI) scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 45 minutes.
intervention type: Device
intervention name: Intracavitary Applicator Placement
description: MRI-compatible applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.
arm group label: Brachytherapy Treatment Planning
other name: MDA Applicator
intervention type: Other
intervention name: Computed Tomography (CT)
description: CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.
arm group label: Brachytherapy Treatment Planning
other name: CT
intervention type: Other
intervention name: Magnetic Resonance Imaging (MRI)
description: MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.
arm group label: Brachytherapy Treatment Planning
other name: MRI
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ann Klopp, 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: Uterine Cervical Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 