<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/NCT02207179</url>
  </required_header>
  <id_info>
    <org_study_id>LM010</org_study_id>
    <nct_id>NCT02207179</nct_id>
  </id_info>
  <brief_title>Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology</brief_title>
  <official_title>Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology: An Ex-vivo Pilot Study of Real-time Breast Margin Imaging in Women Undergoing Breast Conservation Surgery for Early Stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LumaMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>LumaMed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate LumaScan, an innovative polarization microscope for real time,&#xD;
      intraoperative imaging and evaluation of the surface of excised tissue excised during Breast&#xD;
      Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators&#xD;
      hypothesis is that LumaScan will be comparable for cancer detection to conventional&#xD;
      histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative&#xD;
      images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision&#xD;
      surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and&#xD;
      loss of confidence in the tissue conservation surgery procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LumaScan is an innovative polarization microscope that uses Polarization Subtraction Imaging&#xD;
      (PSI) technology to provide real time, intra operative, digital images of the surface of&#xD;
      tissue removed during BCS for breast cancer. PSI uses polarized visible light for optical&#xD;
      sectioning and geometric imaging of the superficial layers of the surgically removed tissue&#xD;
      while rejecting surface scatter and light from deeper layers. By rejecting light from deeper&#xD;
      tissues PSI is able to exclusively focus on the superficial tissue layers. This also results&#xD;
      in higher resolution images than are possible with standard optical imaging. PSI is used in&#xD;
      both reflectance and fluorescence modes. Reflectance detects morphologic abnormalities that&#xD;
      occur in tumor progression such as increased nuclear density, angiogenesis, cellular&#xD;
      infiltration and crowding while fluorescence detects early biochemical changes.&#xD;
&#xD;
      To enhance the contrast of tumor at the margins the investigators will use Methylene blue&#xD;
      (MB), a dye that has been commonly used in breast surgery for mapping sentinel lymph nodes.&#xD;
      MB can be administered peritumorally and is quickly taken up by cells in only a few minutes&#xD;
      of exposure and its presence does not interfere with or preclude later histopathology on the&#xD;
      same tissue specimen. A tumor specimen may also be dipped in MB post-excision to achieve&#xD;
      tumor margin contrast enhancement and not interfere with pathologic assessment.&#xD;
&#xD;
      Previous research using PSI technology has demonstrated the value of PSI in mapping tumor&#xD;
      boundaries of breast cancer in excised tissue specimens and in non-melanoma skin cancers and&#xD;
      these boundaries in side by side comparisons correlate well with those marked by a&#xD;
      pathologist on representative sections prepared using standard H&amp;E staining procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Early Phase 1</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>Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images.</measure>
    <time_frame>From day of surgery until receipt of pathology results (upto 2 weeks)</time_frame>
    <description>Quantitative metrics (e.g. size or area of tumor found between the two images) will be used to to compare en-face pathology and corresponding LumaScan images from excised breast tissue margins.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pathologist interpretation of LumaScan images (blinded) are similar to those of histopathology images.</measure>
    <time_frame>From day of surgery until receipt of pathology results (upto 2 weeks)</time_frame>
    <description>The Pathologists will be asked to interpret LumaScan images and corresponding histopathology images. The images will be randomly presented to the Pathologist in order to be blinded to each.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeons interpretation of LumaScan images (blinded) are similar to those of histopathology images.</measure>
    <time_frame>From day of surgery until receipt of pathology results (upto 2 weeks)</time_frame>
    <description>To correlate and determine the surgeons blinded interpretation of the LumaScan images, digital photographs vs. the final pathologic outcomes (post image acquisition)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for each margin and bi-valved image acquisition in the operating room</measure>
    <time_frame>Duration of surgery (upto 3 hours)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>LumaScan Image Guided Surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LumaScan Image Guided Surgery</intervention_name>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women referred for breast conservation surgery following a diagnosis of invasive or in&#xD;
             situ carcinoma of the breast by histopathology or women referred for lumpectomy due to&#xD;
             a benign (fibroadenoma or papilloma) or high risk breast lesion(Atypical ductal&#xD;
             hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical&#xD;
             papilloma).&#xD;
&#xD;
          2. 18 years of age or older.&#xD;
&#xD;
          3. Able to read or understand and give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing neo-adjuvant systemic therapy.&#xD;
&#xD;
          2. Previous breast cancer and /or radiation in the operated breast.&#xD;
&#xD;
          3. Implants in the operated breast.&#xD;
&#xD;
          4. Pregnant or Lactating.&#xD;
&#xD;
          5. History of photosensitizing disease (porphyria, lupus etc.) or of allergy to methylene&#xD;
             blue dye.&#xD;
&#xD;
          6. Recent use of photosensitizing agents such as fluoroquinolones and retinoids or&#xD;
             patients undergoing phototherapy.&#xD;
&#xD;
          7. Participation in any other intraoperative margin assessment protocol that would affect&#xD;
             data acquisition.&#xD;
&#xD;
          8. Subareolar location (cancer is directly and completely under the nipple/areolar&#xD;
             complex) of breast abnormality.&#xD;
&#xD;
          9. Patients for whom English is not their native language&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee G Wilke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shabbir B Bambot, PhD</last_name>
    <phone>678-907-4711</phone>
    <email>sbambot@lumamed.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Samuels, MS</last_name>
    <phone>404-376-6726</phone>
    <email>msamuels@lumamed.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Mirrielees, MS</last_name>
      <phone>608-265-1113</phone>
      <email>mirrielees@surgery.wisc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>March 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraoperative</keyword>
  <keyword>Cancer margin</keyword>
  <keyword>Spectroscopy</keyword>
  <keyword>Polarization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT02207179
org study id: LM010
nct id: NCT02207179
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate LumaScan, an innovative polarization microscope for real time,
      intraoperative imaging and evaluation of the surface of excised tissue excised during Breast
      Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators
      hypothesis is that LumaScan will be comparable for cancer detection to conventional
      histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative
      images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision
      surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and
      loss of confidence in the tissue conservation surgery procedure.
LumaScan is an innovative polarization microscope that uses Polarization Subtraction Imaging
      (PSI) technology to provide real time, intra operative, digital images of the surface of
      tissue removed during BCS for breast cancer. PSI uses polarized visible light for optical
      sectioning and geometric imaging of the superficial layers of the surgically removed tissue
      while rejecting surface scatter and light from deeper layers. By rejecting light from deeper
      tissues PSI is able to exclusively focus on the superficial tissue layers. This also results
      in higher resolution images than are possible with standard optical imaging. PSI is used in
      both reflectance and fluorescence modes. Reflectance detects morphologic abnormalities that
      occur in tumor progression such as increased nuclear density, angiogenesis, cellular
      infiltration and crowding while fluorescence detects early biochemical changes.

      To enhance the contrast of tumor at the margins the investigators will use Methylene blue
      (MB), a dye that has been commonly used in breast surgery for mapping sentinel lymph nodes.
      MB can be administered peritumorally and is quickly taken up by cells in only a few minutes
      of exposure and its presence does not interfere with or preclude later histopathology on the
      same tissue specimen. A tumor specimen may also be dipped in MB post-excision to achieve
      tumor margin contrast enhancement and not interfere with pathologic assessment.

      Previous research using PSI technology has demonstrated the value of PSI in mapping tumor
      boundaries of breast cancer in excised tissue specimens and in non-melanoma skin cancers and
      these boundaries in side by side comparisons correlate well with those marked by a
      pathologist on representative sections prepared using standard H&E staining procedures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images.
time frame: From day of surgery until receipt of pathology results (upto 2 weeks)
description: Quantitative metrics (e.g. size or area of tumor found between the two images) will be used to to compare en-face pathology and corresponding LumaScan images from excised breast tissue margins.
measure: Pathologist interpretation of LumaScan images (blinded) are similar to those of histopathology images.
time frame: From day of surgery until receipt of pathology results (upto 2 weeks)
description: The Pathologists will be asked to interpret LumaScan images and corresponding histopathology images. The images will be randomly presented to the Pathologist in order to be blinded to each.
measure: Surgeons interpretation of LumaScan images (blinded) are similar to those of histopathology images.
time frame: From day of surgery until receipt of pathology results (upto 2 weeks)
description: To correlate and determine the surgeons blinded interpretation of the LumaScan images, digital photographs vs. the final pathologic outcomes (post image acquisition)
measure: Time for each margin and bi-valved image acquisition in the operating room
time frame: Duration of surgery (upto 3 hours)
arm group label: Single Arm
arm group type: No Intervention
description: LumaScan Image Guided Surgery
intervention type: Device
intervention name: LumaScan Image Guided Surgery
arm group label: Single Arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Lee G Wilke, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Shabbir B Bambot, PhD
phone: 678-907-4711
email: sbambot@lumamed.com
last name: Mark Samuels, MS
phone: 404-376-6726
email: msamuels@lumamed.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms