<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/NCT01699867</url>
  </required_header>
  <id_info>
    <org_study_id>DxP 2012-02 (Part A)</org_study_id>
    <nct_id>NCT01699867</nct_id>
  </id_info>
  <brief_title>Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)</brief_title>
  <official_title>Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diagnostic Photonics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Diagnostic Photonics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multi-center, prospective, open label study analyzed specimens from fifty subjects at&#xD;
      two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in&#xD;
      accordance with the inclusion and exclusion criteria. The study period per subject was the&#xD;
      time it took to assess the ex vivo breast tissue sample using the study device. Image review&#xD;
      was conducted after surgery and compared to the margin status findings in the post-operative&#xD;
      pathology report.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patients With All Positive Margins Correctly Identified With the Device</measure>
    <time_frame>one week after surgery</time_frame>
    <description>In this study, a patient had &quot;positive margins&quot; if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, &quot;tumor on ink&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Margins With False Positive Device Readings</measure>
    <time_frame>one week after surgery</time_frame>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Breast Cancer</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical coherence tomography</intervention_name>
    <description>Optical coherence tomography was used to image ex vivo breast tissue specimens.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with breast cancer undergoing lumpectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women 18 years of age or older&#xD;
&#xD;
          2. Signed informed consent form&#xD;
&#xD;
          3. Women who have been histologically diagnosed with carcinoma of the breast prior to&#xD;
             surgery&#xD;
&#xD;
          4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy)&#xD;
             procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Multicentric disease (histologically diagnosed cancer in two different quadrants of&#xD;
             the breast)&#xD;
&#xD;
          2. Neoadjuvant systemic therapy&#xD;
&#xD;
          3. All T4 tumors&#xD;
&#xD;
          4. Previous radiation in the operated breast&#xD;
&#xD;
          5. Prior surgical procedure in the same quadrant&#xD;
&#xD;
          6. Implants in the operated breast&#xD;
&#xD;
          7. Pregnancy&#xD;
&#xD;
          8. Lactation&#xD;
&#xD;
          9. Participating in any other investigational study for either drug or device which can&#xD;
             influence collection of valid data under this study&#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>Lisa K Jacobs, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anne Arundel Medical Center</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>December 5, 2014</results_first_submitted>
  <results_first_submitted_qc>December 5, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 12, 2014</results_first_posted>
  <last_update_submitted>December 12, 2014</last_update_submitted>
  <last_update_submitted_qc>December 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lumpectomy</keyword>
  <keyword>breast cancer</keyword>
  <keyword>optical coherence tomography</keyword>
  <keyword>tumor margin</keyword>
  <keyword>imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Optical Coherence Tomography (Single-arm)</title>
          <description>Specimens from all patients were evaluated by optical coherence tomography.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screening Failure</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>47 patients completed the study. 1 patient was excluded from the analysis due to insufficient images in all specimens (did not meet protocol specifications).</population>
      <group_list>
        <group group_id="B1">
          <title>Optical Coherence Tomography (Single-arm)</title>
          <description>Specimens from all patients were evaluated by optical coherence tomography.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62" lower_limit="27" upper_limit="81"/>
                  </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="46"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patients With All Positive Margins Correctly Identified With the Device</title>
        <description>In this study, a patient had &quot;positive margins&quot; if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, &quot;tumor on ink&quot;).</description>
        <time_frame>one week after surgery</time_frame>
        <population>Patients with positive margins (0 mm, &quot;tumor on ink&quot;).</population>
        <group_list>
          <group group_id="O1">
            <title>Optical Coherence Tomography (Single-arm)</title>
            <description>Specimens from all patients were evaluated by optical coherence tomography.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients With All Positive Margins Correctly Identified With the Device</title>
          <description>In this study, a patient had &quot;positive margins&quot; if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, &quot;tumor on ink&quot;).</description>
          <population>Patients with positive margins (0 mm, &quot;tumor on ink&quot;).</population>
          <units>Patients w/ all positives identified</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Margins With False Positive Device Readings</title>
        <time_frame>one week after surgery</time_frame>
        <population>Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.</population>
        <group_list>
          <group group_id="O1">
            <title>Optical Coherence Tomography (Single-arm)</title>
            <description>Specimens from all patients were evaluated by optical coherence tomography.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Margins With False Positive Device Readings</title>
          <population>Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.</population>
          <units>False positive margins per patient</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the surgical procedure.</time_frame>
      <desc>The investigational device only contacted excised patient tissue. The device did not contact patients as part of this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Patients (Single-arm)</title>
          <description>All enrolled study patients.</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="47"/>
              </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="47"/>
              </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>Lisa K. Jacobs, M.D.</name_or_title>
      <organization>Johns Hopkins Medicine</organization>
      <phone>410-502-0880</phone>
      <email>ljacob14@jhmi.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/NCT01699867
org study id: DxP 2012-02 (Part A)
nct id: NCT01699867
lead sponsor: 
collaborator: 
has dmc: No
This multi-center, prospective, open label study analyzed specimens from fifty subjects at
      two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in
      accordance with the inclusion and exclusion criteria. The study period per subject was the
      time it took to assess the ex vivo breast tissue sample using the study device. Image review
      was conducted after surgery and compared to the margin status findings in the post-operative
      pathology report.
observational model: Cohort
time perspective: Prospective
measure: Patients With All Positive Margins Correctly Identified With the Device
time frame: one week after surgery
description: In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").
measure: Number of Margins With False Positive Device Readings
time frame: one week after surgery
intervention type: Device
intervention name: Optical coherence tomography
description: Optical coherence tomography was used to image ex vivo breast tissue specimens.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lisa K Jacobs, M.D.
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 