<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/NCT01661062</url>
  </required_header>
  <id_info>
    <org_study_id>2005.084</org_study_id>
    <secondary_id>HUM 757</secondary_id>
    <nct_id>NCT01661062</nct_id>
  </id_info>
  <brief_title>A Study Using Cone Beam CT for Head and Neck Cancer</brief_title>
  <official_title>A Pilot Study of Tumor and Critical Normal Tissue Motion in Head and Neck Cancer Using Cone Beam CT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cone beam CT (computed tomography) is a developing technology which allows CT images to be&#xD;
      obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to&#xD;
      produce detailed pictures of structures in the body.) In this study, cone beam CT scans will&#xD;
      be obtained before individual radiation treatment sessions for head and neck cancer. The&#xD;
      information gathered from these scans will be used by the researchers to look at patient&#xD;
      movement as well as changes in the amount of normal and tumor tissue throughout the course of&#xD;
      radiation therapy. The researchers will use this information to create hypothetical radiation&#xD;
      treatment plans, which will be used as the basis for future research. The cone beam CT scan&#xD;
      data will not be used to alter the actual radiation treatment of any of the patients enrolled&#xD;
      on the study. In addition, tests of salivary output and swallowing and questionnaires about&#xD;
      quality of life will be made to assess how the doses of radiation affect them.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2011</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Movement of Normal Tissue</measure>
    <time_frame>approximately 7 weeks</time_frame>
    <description>The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate</measure>
    <time_frame>24 months</time_frame>
    <description>Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of Image Quality</measure>
    <time_frame>36 months</time_frame>
    <description>Use acquired data to further improve cone beam CT reconstruction techniques and image quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Median Delivered Dose of Radiation to the Parotid Gland</measure>
    <time_frame>7 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Cone Beam CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will be included in the treatment arm of this study. For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently). Although the exact amount of radiation patients get will be determined by their doctor, it is expected that they will get approximately 7 weeks, approximately 35 total cone beam CT scans.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cone Beam Computed Tomography (CT) Scan</intervention_name>
    <description>Cone beam CT scan is considered a noninvasive procedure (meaning that the procedure does not require breaking the skin or any tools that physically enter the body). It will add a small amount of additional radiation dose (less than 1%) to the head and neck. The increase in the amount of radiation is only a very small amount more than what patients who get standard daily imaging receive. The amount of radiation from the cone beam CT scans is not significant (less than 1%) when compared to the amount of radiation generally received for treatment of head and neck cancer.</description>
    <arm_group_label>Cone Beam CT</arm_group_label>
    <other_name>CBCT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of all ages ≥18, both sexes, and all races will be included in this study.&#xD;
             Pregnant females will be excluded. No other special classes of subjects (i.e.,&#xD;
             prisoners) will be entered.&#xD;
&#xD;
          -  Patients must be diagnosed with biopsy-proven squamous cell carcinoma of the head and&#xD;
             neck.&#xD;
&#xD;
          -  Patients must be recommended treatment with definitive radiation therapy with&#xD;
             concurrent chemotherapy, but without prior surgical resection of the primary tumor or&#xD;
             lymph nodes&#xD;
&#xD;
          -  Patients must be recommended a treatment course of at least 30 radiation fractions&#xD;
&#xD;
          -  Patients must sign an informed consent form approved for this purpose by the&#xD;
             Institutional Review Board (IRB) of the University of Michigan Hospital indicating&#xD;
             that they are aware that undergoing cone beam CT of the head and neck is voluntary and&#xD;
             has potential risks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients must not have a history of prior radiation to the head or neck&#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>Avraham Eisbruch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Rogel Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Hunter KU, Fernandes LL, Vineberg KA, McShan D, Antonuk AE, Cornwall C, Feng M, Schipper MJ, Balter JM, Eisbruch A. Parotid glands dose-effect relationships based on their actually delivered doses: implications for adaptive replanning in radiation therapy of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):676-82. doi: 10.1016/j.ijrobp.2013.07.040. Epub 2013 Sep 10.</citation>
    <PMID>24035328</PMID>
  </results_reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 26, 2011</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <results_first_submitted>October 21, 2014</results_first_submitted>
  <results_first_submitted_qc>October 24, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 31, 2014</results_first_posted>
  <last_update_submitted>July 26, 2016</last_update_submitted>
  <last_update_submitted_qc>July 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cone Beam CT</title>
          <description>For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).&#xD;
Radiotherapy will be delivered according to current guidelines.&#xD;
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Completed Treatment Off Study</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Although 23 patients were enrolled, only 18 completed treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Cone Beam CT</title>
          <description>For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).&#xD;
Radiotherapy will be delivered according to current guidelines.&#xD;
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="57" lower_limit="50" upper_limit="76"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease Site</title>
          <description>Location of the disease at baseline.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Base of Tongue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tonsil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>T Stage</title>
          <description>The T stage represents the size and stage of the primary tumor:&#xD;
TX: Primary tumor cannot be evaluated T0: No evidence of primary tumor Tis: Carcinoma in situ (CIS; abnormal cells are present but have not spread to neighboring tissue; although not cancer, CIS may become cancer and is sometimes called preinvasive cancer) T1, T2, T3, T4: Size and/or extent of the primary tumor (higher numbers represent more extensive disease)</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>N Stage</title>
          <description>The N stage represents the amount of spread to nearby lymph nodes:&#xD;
NX: Regional lymph nodes cannot be evaluated N0: No regional lymph node involvement N1, N2, N3: Degree of regional lymph node involvement (number and location of lymph nodes)</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>N0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N2a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N2b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N2c</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-Treatment Weight</title>
          <units>lb</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="203" lower_limit="105" upper_limit="308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Movement of Normal Tissue</title>
        <description>The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.</description>
        <time_frame>approximately 7 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement of Image Quality</title>
        <description>Use acquired data to further improve cone beam CT reconstruction techniques and image quality.</description>
        <time_frame>36 months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Median Delivered Dose of Radiation to the Parotid Gland</title>
        <time_frame>7 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cone Beam CT</title>
            <description>For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).&#xD;
Radiotherapy will be delivered according to current guidelines.&#xD;
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>The Median Delivered Dose of Radiation to the Parotid Gland</title>
          <units>Gy</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.4" lower_limit="23.2" upper_limit="63.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate</title>
        <description>Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).</description>
        <time_frame>24 months</time_frame>
        <population>36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Cone Beam CT</title>
            <description>For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).&#xD;
Radiotherapy will be delivered according to current guidelines.&#xD;
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate</title>
          <description>Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).</description>
          <population>36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cone Beam CT</title>
          <description>For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).&#xD;
Radiotherapy will be delivered according to current guidelines.&#xD;
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="9" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>xerostomia</sub_title>
                <counts group_id="E1" events="30" subjects_affected="9" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="9" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="8" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Other</sub_title>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Mucositis/Stomatitis (symptomatic)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Salivary Gland Changes</sub_title>
                <counts group_id="E1" events="22" subjects_affected="7" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="9" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Mucositis/Stomatitis (upon exam)</sub_title>
                <counts group_id="E1" events="25" subjects_affected="9" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="15" subjects_affected="8" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Chemoradiation Rash</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Radiation Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="18"/>
              </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>Avraham Eisbruch, M.D.</name_or_title>
      <organization>University of Michigan Comprehensive Cancer Center</organization>
      <phone>734-936-4302</phone>
      <email>eisbruch@umich.edu</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/NCT01661062
org study id: 2005.084
secondary id: HUM 757
nct id: NCT01661062
lead sponsor: 
has dmc: Yes
Cone beam CT (computed tomography) is a developing technology which allows CT images to be
      obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to
      produce detailed pictures of structures in the body.) In this study, cone beam CT scans will
      be obtained before individual radiation treatment sessions for head and neck cancer. The
      information gathered from these scans will be used by the researchers to look at patient
      movement as well as changes in the amount of normal and tumor tissue throughout the course of
      radiation therapy. The researchers will use this information to create hypothetical radiation
      treatment plans, which will be used as the basis for future research. The cone beam CT scan
      data will not be used to alter the actual radiation treatment of any of the patients enrolled
      on the study. In addition, tests of salivary output and swallowing and questionnaires about
      quality of life will be made to assess how the doses of radiation affect them.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Movement of Normal Tissue
time frame: approximately 7 weeks
description: The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.
measure: Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
time frame: 24 months
description: Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
measure: Improvement of Image Quality
time frame: 36 months
description: Use acquired data to further improve cone beam CT reconstruction techniques and image quality.
measure: The Median Delivered Dose of Radiation to the Parotid Gland
time frame: 7 weeks
arm group label: Cone Beam CT
arm group type: Experimental
description: All patients will be included in the treatment arm of this study. For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently). Although the exact amount of radiation patients get will be determined by their doctor, it is expected that they will get approximately 7 weeks, approximately 35 total cone beam CT scans.
intervention type: Other
intervention name: Cone Beam Computed Tomography (CT) Scan
description: Cone beam CT scan is considered a noninvasive procedure (meaning that the procedure does not require breaking the skin or any tools that physically enter the body). It will add a small amount of additional radiation dose (less than 1%) to the head and neck. The increase in the amount of radiation is only a very small amount more than what patients who get standard daily imaging receive. The amount of radiation from the cone beam CT scans is not significant (less than 1%) when compared to the amount of radiation generally received for treatment of head and neck cancer.
arm group label: Cone Beam CT
other name: CBCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Avraham Eisbruch, MD
role: Principal Investigator
affiliation: University of Michigan Rogel Cancer Center
facility: 
country: United States
citation: Hunter KU, Fernandes LL, Vineberg KA, McShan D, Antonuk AE, Cornwall C, Feng M, Schipper MJ, Balter JM, Eisbruch A. Parotid glands dose-effect relationships based on their actually delivered doses: implications for adaptive replanning in radiation therapy of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):676-82. doi: 10.1016/j.ijrobp.2013.07.040. Epub 2013 Sep 10.
PMID: 24035328
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 