<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/NCT03035487</url>
  </required_header>
  <id_info>
    <org_study_id>2016-UHR-001</org_study_id>
    <nct_id>NCT03035487</nct_id>
  </id_info>
  <brief_title>Urology of Virginia Case Series</brief_title>
  <official_title>Urology of Virginia Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exact Imaging</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Exact Imaging</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigational protocol describes a small case series designed to compare three imaging&#xD;
      modalities for use in visualizing prostate cancer.&#xD;
&#xD;
      The three modalities to be tested are: transrectal micro-ultrasound , and conventional&#xD;
      resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the&#xD;
      multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI&#xD;
      (mpMRI).&#xD;
&#xD;
      These modalities will be used for guiding systematic (standard, random, extended sextant)&#xD;
      plus image-guided targeted prostate biopsies among men with known cancer and an indication&#xD;
      for prostate biopsy.&#xD;
&#xD;
      In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the&#xD;
      radiology report used for targeting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will enroll nine men with an indication for a prostate biopsy.&#xD;
&#xD;
      The primary objective of the study is to provide guidance to clinicians who will be using the&#xD;
      ExactVu system on the appearance of suspicious foci, and the difference between the&#xD;
      appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.&#xD;
&#xD;
      The study is being conducted based on the hypothesis that a series of same-subject&#xD;
      comparisons will clearly demonstrate the differences in appearance between the modalities.&#xD;
&#xD;
      Procedures in the study are:&#xD;
&#xD;
        -  obtain informed consent for the subject&#xD;
&#xD;
        -  image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain&#xD;
           radiologist's report&#xD;
&#xD;
        -  perform biopsy procedure using micro-ultrasound (this may be conducted in a separate&#xD;
           subject visit)&#xD;
&#xD;
        -  prepare biopsy specimens for pathology&#xD;
&#xD;
        -  record all procedure details in a case report form, including pathology and mpMRI&#xD;
           reports&#xD;
&#xD;
      The primary endpoint will be a standardized description using keywords of each biopsy sample&#xD;
      region. These descriptions will be recorded during the blinded readings after the procedure&#xD;
      to avoid added procedure time and will be used to compare appearance between the modalities.&#xD;
&#xD;
      Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and&#xD;
      percentage of cancer in sample), and risk score identified on imaging. Both of these values&#xD;
      are per-sample, with 12 systematic samples per subject plus any additional targeted samples&#xD;
      warranted by standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Keyword Description of Each Biopsy Sample</measure>
    <time_frame>For each patient, keywords will be assigned within one week following the patient's procedure.</time_frame>
    <description>The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Cancer of the PROSTATE</condition>
  <condition>Prostatic Neoplasm</condition>
  <arm_group>
    <arm_group_label>Micro-ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:&#xD;
Low resolution transrectal ultrasound examination (&quot;LR-TRUS&quot;)&#xD;
Multi-parametric MRI (&quot;mpMRI&quot;) examination performed according to the PI-RADS v2 protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound guided prostate exam using SOC ultrasound system</intervention_name>
    <arm_group_label>Micro-ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mpMRI guided prostate examination using PI-RADS v2</intervention_name>
    <description>mpMRI guided prostate examination using standard of care MRI system</description>
    <arm_group_label>Micro-ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-resolution micro-ultrasound guided prostate biopsy</intervention_name>
    <arm_group_label>Micro-ultrasound</arm_group_label>
    <other_name>ExactVu micro-ultrasound imaging system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All men ≥ 40 years age and &lt;80 years of age with a history of prostate cancer and an&#xD;
             indication for a prostate biopsy will be offered inclusion in the study. Typical&#xD;
             indications for biopsy include abnormal PSA (prostate specific antigen) and/or&#xD;
             abnormal DRE (digital rectal exam) and/or history of prostate cancer.&#xD;
&#xD;
          2. PSA&lt;50&#xD;
&#xD;
          3. Clinical stage &lt; cT2c&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded from being included in the investigation if any of the following&#xD;
        is true:&#xD;
&#xD;
          1. Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia&#xD;
&#xD;
          2. Men with known prostate volume (from prior imaging) of &gt; 60cc&#xD;
&#xD;
          3. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy&#xD;
&#xD;
          4. Men who are unable to provide their own informed consent&#xD;
&#xD;
          5. Men who have contraindications to MRI or gadolinium chelate contrast&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Urology of Virginia</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>November 5, 2018</results_first_submitted>
  <results_first_submitted_qc>November 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 4, 2019</results_first_posted>
  <last_update_submitted>April 30, 2019</last_update_submitted>
  <last_update_submitted_qc>April 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Micro-ultrasound</title>
          <description>Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:&#xD;
Low resolution transrectal ultrasound examination (&quot;LR-TRUS&quot;)&#xD;
Multi-parametric MRI (&quot;mpMRI&quot;) examination performed according to the PI-RADS v2 protocol&#xD;
Ultrasound guided prostate exam using SOC ultrasound system&#xD;
mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system&#xD;
High-resolution micro-ultrasound guided prostate biopsy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Micro-ultrasound</title>
          <description>Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:&#xD;
Low resolution transrectal ultrasound examination (&quot;LR-TRUS&quot;)&#xD;
Multi-parametric MRI (&quot;mpMRI&quot;) examination performed according to the PI-RADS v2 protocol&#xD;
Ultrasound guided prostate exam using SOC ultrasound system&#xD;
mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system&#xD;
High-resolution micro-ultrasound guided prostate biopsy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Keyword Description of Each Biopsy Sample</title>
        <description>The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.</description>
        <time_frame>For each patient, keywords will be assigned within one week following the patient's procedure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Micro-ultrasound</title>
            <description>Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:&#xD;
Low resolution transrectal ultrasound examination (&quot;LR-TRUS&quot;)&#xD;
Multi-parametric MRI (&quot;mpMRI&quot;) examination performed according to the PI-RADS v2 protocol&#xD;
Ultrasound guided prostate exam using SOC ultrasound system&#xD;
mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system&#xD;
High-resolution micro-ultrasound guided prostate biopsy</description>
          </group>
        </group_list>
        <measure>
          <title>Keyword Description of Each Biopsy Sample</title>
          <description>The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.</description>
          <units>percentage significant cancers detected</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Micro-ultrasound</title>
          <description>Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:&#xD;
Low resolution transrectal ultrasound examination (&quot;LR-TRUS&quot;)&#xD;
Multi-parametric MRI (&quot;mpMRI&quot;) examination performed according to the PI-RADS v2 protocol&#xD;
Ultrasound guided prostate exam using SOC ultrasound system&#xD;
mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system&#xD;
High-resolution micro-ultrasound guided prostate biopsy</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="0" subjects_at_risk="9"/>
              </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="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Manager, Clinical Research</name_or_title>
      <organization>Exact Imaging</organization>
      <phone>905-415-0030 ext 204</phone>
      <email>bwodlinger@exactimaging.com</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/NCT03035487
org study id: 2016-UHR-001
nct id: NCT03035487
lead sponsor: 
has dmc: No
The investigational protocol describes a small case series designed to compare three imaging
      modalities for use in visualizing prostate cancer.

      The three modalities to be tested are: transrectal micro-ultrasound , and conventional
      resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the
      multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI
      (mpMRI).

      These modalities will be used for guiding systematic (standard, random, extended sextant)
      plus image-guided targeted prostate biopsies among men with known cancer and an indication
      for prostate biopsy.

      In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the
      radiology report used for targeting.
This trial will enroll nine men with an indication for a prostate biopsy.

      The primary objective of the study is to provide guidance to clinicians who will be using the
      ExactVu system on the appearance of suspicious foci, and the difference between the
      appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.

      The study is being conducted based on the hypothesis that a series of same-subject
      comparisons will clearly demonstrate the differences in appearance between the modalities.

      Procedures in the study are:

        -  obtain informed consent for the subject

        -  image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain
           radiologist's report

        -  perform biopsy procedure using micro-ultrasound (this may be conducted in a separate
           subject visit)

        -  prepare biopsy specimens for pathology

        -  record all procedure details in a case report form, including pathology and mpMRI
           reports

      The primary endpoint will be a standardized description using keywords of each biopsy sample
      region. These descriptions will be recorded during the blinded readings after the procedure
      to avoid added procedure time and will be used to compare appearance between the modalities.

      Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and
      percentage of cancer in sample), and risk score identified on imaging. Both of these values
      are per-sample, with 12 systematic samples per subject plus any additional targeted samples
      warranted by standard of care.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Keyword Description of Each Biopsy Sample
time frame: For each patient, keywords will be assigned within one week following the patient's procedure.
description: The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
arm group label: Micro-ultrasound
arm group type: Experimental
description: Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
Low resolution transrectal ultrasound examination ("LR-TRUS")
Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol
intervention type: Device
intervention name: Ultrasound guided prostate exam using SOC ultrasound system
arm group label: Micro-ultrasound
intervention type: Device
intervention name: mpMRI guided prostate examination using PI-RADS v2
description: mpMRI guided prostate examination using standard of care MRI system
arm group label: Micro-ultrasound
intervention type: Device
intervention name: High-resolution micro-ultrasound guided prostate biopsy
arm group label: Micro-ultrasound
other name: ExactVu micro-ultrasound imaging system
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 