<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/NCT01681901</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-06010</org_study_id>
    <secondary_id>NCI-2012-01176</secondary_id>
    <nct_id>NCT01681901</nct_id>
  </id_info>
  <brief_title>Ultrasound in Detecting Lymph Node Metastasis in Older Patients Undergoing Breast Sonography</brief_title>
  <official_title>Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older&#xD;
      patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may&#xD;
      help find breast cancer and find out how far the disease has spread&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To develop a reliable and consistent set of guidelines for utilizing diagnostic ultrasound&#xD;
      to assess axillary lymph nodes for patient suspicious of breast cancer with possible nodal&#xD;
      metastasis.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To explore whether the data collected can be used for pathologic validation of metastatic&#xD;
      disease.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo breast ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no patient accrual&#xD;
  </why_stopped>
  <start_date type="Actual">June 7, 2006</start_date>
  <completion_date type="Anticipated">April 2007</completion_date>
  <primary_completion_date type="Anticipated">April 2007</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of successful evaluations, defined as the consistent capture of the data for geometry, morphology, qualitative vascular information, and quantitative vascular information on 3 axillary lymph nodes</measure>
    <time_frame>at 15 minutes following breast sonogram</time_frame>
    <description>The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =&lt; 0.7.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes</measure>
    <time_frame>3 months</time_frame>
    <description>Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The longitudinal-transverse ratio will be investigated for cutoff points that yield high sensitivity and to see if results are consistent with prior studies suggesting a ratio of 1.5 or less is indicative of abnormality. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of lymph node morphology, assessed for shape and echogenicity, to determine guidelines for characterizing micro metastases to the lymph nodes</measure>
    <time_frame>3 months</time_frame>
    <description>Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes</measure>
    <time_frame>3 months</time_frame>
    <description>Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes</measure>
    <time_frame>3 months</time_frame>
    <description>Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Diagnostic (ultrasound)</arm_group_label>
    <description>Patients undergo breast ultrasound imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ultrasound imaging</intervention_name>
    <description>Undergo ultrasound</description>
    <arm_group_label>Diagnostic (ultrasound)</arm_group_label>
    <other_name>ultrasonography</other_name>
    <other_name>ultrasound</other_name>
    <other_name>ultrasound test</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred for a breast ultrasound&#xD;
&#xD;
          -  Patients who have had a mammogram with a Breast Imaging Reporting and Data System&#xD;
             (BIRADS) of &gt;= 4&#xD;
&#xD;
          -  Patients who are undiagnosed for breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred for a breast ultrasound&#xD;
&#xD;
          -  Patients who have had a mammogram with a Breast Imaging Reporting and Data System&#xD;
             (BIRADS) of &gt;= 4&#xD;
&#xD;
          -  Patients who are undiagnosed for breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had breast cancer surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Evans</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamelsine</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01681901
org study id: OSU-06010
secondary id: NCI-2012-01176
nct id: NCT01681901
lead sponsor: 
has dmc: Yes
This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older
      patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may
      help find breast cancer and find out how far the disease has spread
PRIMARY OBJECTIVES:

      I. To develop a reliable and consistent set of guidelines for utilizing diagnostic ultrasound
      to assess axillary lymph nodes for patient suspicious of breast cancer with possible nodal
      metastasis.

      SECONDARY OBJECTIVES:

      I. To explore whether the data collected can be used for pathologic validation of metastatic
      disease.

      OUTLINE:

      Patients undergo breast ultrasound.
observational model: Cohort
time perspective: Cross-Sectional
measure: Proportion of successful evaluations, defined as the consistent capture of the data for geometry, morphology, qualitative vascular information, and quantitative vascular information on 3 axillary lymph nodes
time frame: at 15 minutes following breast sonogram
description: The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =< 0.7.
measure: Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes
time frame: 3 months
description: Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The longitudinal-transverse ratio will be investigated for cutoff points that yield high sensitivity and to see if results are consistent with prior studies suggesting a ratio of 1.5 or less is indicative of abnormality. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.
measure: Accuracy of lymph node morphology, assessed for shape and echogenicity, to determine guidelines for characterizing micro metastases to the lymph nodes
time frame: 3 months
description: Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.
measure: Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes
time frame: 3 months
description: Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.
measure: Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes
time frame: 3 months
description: Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.
arm group label: Diagnostic (ultrasound)
description: Patients undergo breast ultrasound imaging.
intervention type: Procedure
intervention name: ultrasound imaging
description: Undergo ultrasound
arm group label: Diagnostic (ultrasound)
other name: ultrasonography
other name: ultrasound
other name: ultrasound test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin Evans
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
country: United States
url: http://cancer.osu.edu
description: The Jamelsine
responsible party type: Sponsor