<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/NCT03013413</url>
  </required_header>
  <id_info>
    <org_study_id>11D.349</org_study_id>
    <nct_id>NCT03013413</nct_id>
  </id_info>
  <brief_title>Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy</brief_title>
  <official_title>Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies an ultrasound-based imaging procedure called elastography using&#xD;
      the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound&#xD;
      is a non-invasive imaging technique that uses high-frequency sound waves to produce images of&#xD;
      internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness&#xD;
      or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet&#xD;
      known whether elastography imaging using the Aixplorer system works better than standard&#xD;
      ultrasound imaging in detecting prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the detection of prostate cancer with elastography using the Aixplorer&#xD;
      scanner.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To obtain quantitative data on the elastic properties of normal and malignant tissue in&#xD;
      the prostate of patients referred for ultrasound guided biopsy.&#xD;
&#xD;
      II. To compare the Gleason grade of prostate cancers detected with elastography to the&#xD;
      Gleason grade of tumors detected by conventional systematic biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner</measure>
    <time_frame>At the time of prostate biopsy</time_frame>
    <description>Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy</measure>
    <time_frame>At the time of prostate biopsy</time_frame>
    <description>Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Prostate Carcinoma</condition>
  <arm_group>
    <arm_group_label>Diagnostic (elastography imaging using the Aixplorer system)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Shear Wave Elastography</intervention_name>
    <description>Undergo ultrasound-based elastography imaging using the Aixplorer system</description>
    <arm_group_label>Diagnostic (elastography imaging using the Aixplorer system)</arm_group_label>
    <other_name>Transient Elastography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound Elasticity Imaging</intervention_name>
    <description>Undergo ultrasound-based elastography imaging using the Aixplorer system</description>
    <arm_group_label>Diagnostic (elastography imaging using the Aixplorer system)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-Guided Prostate Biopsy</intervention_name>
    <description>Undergo standard of care ultrasound-guided prostate biopsy</description>
    <arm_group_label>Diagnostic (elastography imaging using the Aixplorer system)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be scheduled for a clinically indicated biopsy of the prostate&#xD;
&#xD;
          -  Agree to an ultrasound examination using the Aixplorer system&#xD;
&#xD;
          -  Sign an institutional review board (IRB) approved informed consent prior to any study&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Recent prostate biopsy within 90 days&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ethan Halpern, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</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>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03013413
org study id: 11D.349
nct id: NCT03013413
lead sponsor: 
has dmc: No
This clinical trial studies an ultrasound-based imaging procedure called elastography using
      the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound
      is a non-invasive imaging technique that uses high-frequency sound waves to produce images of
      internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness
      or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet
      known whether elastography imaging using the Aixplorer system works better than standard
      ultrasound imaging in detecting prostate cancer.
PRIMARY OBJECTIVES:

      I. To evaluate the detection of prostate cancer with elastography using the Aixplorer
      scanner.

      SECONDARY OBJECTIVES:

      I. To obtain quantitative data on the elastic properties of normal and malignant tissue in
      the prostate of patients referred for ultrasound guided biopsy.

      II. To compare the Gleason grade of prostate cancers detected with elastography to the
      Gleason grade of tumors detected by conventional systematic biopsy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
time frame: At the time of prostate biopsy
description: Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.
measure: Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy
time frame: At the time of prostate biopsy
description: Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient).
arm group label: Diagnostic (elastography imaging using the Aixplorer system)
arm group type: Experimental
description: Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.
intervention type: Procedure
intervention name: Shear Wave Elastography
description: Undergo ultrasound-based elastography imaging using the Aixplorer system
arm group label: Diagnostic (elastography imaging using the Aixplorer system)
other name: Transient Elastography
intervention type: Procedure
intervention name: Ultrasound Elasticity Imaging
description: Undergo ultrasound-based elastography imaging using the Aixplorer system
arm group label: Diagnostic (elastography imaging using the Aixplorer system)
intervention type: Procedure
intervention name: Ultrasound-Guided Prostate Biopsy
description: Undergo standard of care ultrasound-guided prostate biopsy
arm group label: Diagnostic (elastography imaging using the Aixplorer system)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ethan Halpern, MD
role: Principal Investigator
affiliation: Thomas Jefferson University
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Prostatic Neoplasms