<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/NCT04440982</url>
  </required_header>
  <id_info>
    <org_study_id>CLP0008</org_study_id>
    <secondary_id>1R01CA212138-01</secondary_id>
    <nct_id>NCT04440982</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients</brief_title>
  <official_title>Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lumicell, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lumicell, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, randomized, clinical trial evaluating patients&#xD;
      undergoing breast conserving surgery using the LUM Imaging System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed Description:&#xD;
&#xD;
      All subjects will be injected with LUM015. The injection of the study drug will occur 2-6&#xD;
      hours prior to surgery at a dose of 1.0 mg/kg. For all subjects, surgeons will perform main&#xD;
      specimen resection per standard of care. For subjects randomized to the intervention arm, the&#xD;
      surgeon will use the Lum System to scan and image all orientations within the cavity and The&#xD;
      LUM Imaging System will guide shave removal. Then, for all subjects (control and intervention&#xD;
      arm), comprehensive shaved margins are removed.&#xD;
&#xD;
      In this study, the initial cohort is a &quot;training set&quot; with 10 patients receiving neoadjuvant&#xD;
      therapy to refine the tumor detection algorithm, if needed. After completion of enrollment of&#xD;
      the initial 10 subjects for algorithm training, the Investigators will then enroll a cohort&#xD;
      of patients who received neoadjuvant therapy to further evaluate the performance of the LUM&#xD;
      Imaging System in this important subset of breast cancer patients. Concurrently to the&#xD;
      enrollment of this cohort, surgeons will also enroll a cohort of patients who did not receive&#xD;
      neoadjuvant therapy prior to surgery. Patients will be randomized 3:1 to a LUM-assisted&#xD;
      lumpectomy versus a standard lumpectomy. In both arms, shaved margins will be taken from the&#xD;
      entire lumpectomy cavity to compare the extent of residual tumor after standard and&#xD;
      LUM-assisted lumpectomies to evaluate the negative predictive value of the LUM Imaging System&#xD;
      following neoadjuvant therapy. Only the group of patients randomized to the device&#xD;
      (intervention) arm will have the LUM Imaging System guide the removal of tissue prior to the&#xD;
      removal of final comprehensive shaves of the entire cavity.&#xD;
&#xD;
      Study treatment ends when the surgery is completed. Patients are followed for adverse events&#xD;
      until their standard of care follow-up visit or after any secondary surgery, whichever is&#xD;
      longer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Masking will only be applied until main lumpectomy is removed. At time of randomization, the study arm will be revealed to the study team.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy</measure>
    <time_frame>1 month</time_frame>
    <description>Refining of the previously validated tumor detection algorithm in breast cancer patients receiving neoadjuvant therapy will be conducted in the first cohort and the validation of this algorithm will use data from the second cohort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with reported adverse events</measure>
    <time_frame>14 days</time_frame>
    <description>Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in residual tumor</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluate reduction in residual tumor left after Lumicell assisted lumpectomy compared with SoC removal of main lumpectomy specimen in patients who have received and not received neo-adjuvant therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Report on patient reported outcomes and patient preference information</measure>
    <time_frame>12 months</time_frame>
    <description>Collect and summarize patient reported information on outcomes and preference</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">323</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Neoadjuvant Therapy</condition>
  <arm_group>
    <arm_group_label>Device Intervention: LUM Imaging System used during surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The LUM Imaging Device will be used to look inside the lumpectomy cavity to see if the dye indicates any areas that may contain residual tumor. If the imaging identifies that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an additional piece of tissue. This process will be continued until a negative reading from the device is obtained or a maximum of 2 shaves of additional tissue has been removed. Patients in this arm will receive the study drug, LUM015</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Study Device Arm</intervention_name>
    <description>LUM015 will be administered 2 to 6 hours prior to surgery. The LUM Imaging device will be used to assist in the removal of additional tumor tissue.</description>
    <arm_group_label>Device Intervention: LUM Imaging System used during surgery</arm_group_label>
    <other_name>LUM Imaging System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have histologically or cytologically confirmed primary invasive breast&#xD;
             cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS&#xD;
             component.&#xD;
&#xD;
          -  Female, age of 18 years or older.&#xD;
&#xD;
          -  Subjects must have received neoadjuvant therapy for this breast cancer diagnosis prior&#xD;
             to their lumpectomy procedure (cohorts 1 and 2).&#xD;
&#xD;
          -  Subjects must be scheduled for a lumpectomy for a breast malignancy.&#xD;
&#xD;
          -  Subjects must be able and willing to follow study procedures and instructions.&#xD;
&#xD;
          -  Subjects must have received and signed an informed consent form.&#xD;
&#xD;
          -  Subjects must have no uncontrolled serious medical problems except for the diagnosis&#xD;
             of cancer, as per the exclusion criteria listed below.&#xD;
&#xD;
               -  Leukocytes &gt; 1,000/mcL&#xD;
&#xD;
               -  Platelets &gt; 50,000/mcL&#xD;
&#xD;
               -  total bilirubin within normal institutional limits&#xD;
&#xD;
               -  AST (SGOT)/ALT (SGPT) &lt; 2.5 X institutional upper limit of normal&#xD;
&#xD;
               -  eGFR &gt;= 60mL/min/1.73m2&#xD;
&#xD;
          -  Subjects with ECOG performance status of 0 or 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have been diagnosed with bilateral breast cancer and are undergoing&#xD;
             bilateral resection procedure.&#xD;
&#xD;
          -  Subjects who are pregnant at the time of diagnosis of their breast cancer.&#xD;
             Breastfeeding should be discontinued if the mother is treated with LUM015.&#xD;
&#xD;
          -  Subjects who are sexually active and not willing/able to use medically acceptable&#xD;
             forms of contraception (hormonal or barrier method of birth control, abstinence) upon&#xD;
             entering the study and for 60 days after injection of LUM015.&#xD;
&#xD;
          -  Subjects who have taken an investigational drug within 14 days of enrollment.&#xD;
&#xD;
          -  Subjects who will have administration of methylene blue or any blue or green dye for&#xD;
             sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy&#xD;
             cavity with the LUM Imaging Device.&#xD;
&#xD;
          -  Subjects who have not recovered from adverse events due to other pharmaceutical or&#xD;
             diagnostic agents.&#xD;
&#xD;
          -  Subjects with uncontrolled hypertension defined as persistent systolic blood pressure&#xD;
             &gt; 180 mm Hg, or diastolic blood pressure &gt; 110 mm Hg; those subjects with known HTN&#xD;
             should be stable within these ranges while under pharmaceutical therapy.&#xD;
&#xD;
          -  Subjects with a history of allergic reaction to polyethylene glycol (PEG).&#xD;
&#xD;
          -  Subjects with a history of allergic reaction to any oral or intravenous contrast&#xD;
             agents.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or&#xD;
             psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements.&#xD;
&#xD;
          -  HIV-positive individuals on combination antiretroviral therapy are ineligible because&#xD;
             of the potential for pharmacokinetic interactions with LUM015.&#xD;
&#xD;
          -  Any subject for whom the investigator feels participation is not in the best interest&#xD;
             of the subject.&#xD;
&#xD;
          -  Subjects undergoing a second lumpectomy procedure because of positive margins in a&#xD;
             previous surgery prior to entering this study.&#xD;
&#xD;
          -  Subjects with prior ipsilateral breast cancer surgeries, mastectomies, breast&#xD;
             reconstructions or implants.&#xD;
&#xD;
          -  Subjects who have undergone a surgical biopsy for any reason in the ipsilateral breast&#xD;
             performed less than 2 years prior to enrollment of this study.&#xD;
&#xD;
          -  Subjects with prior ipsilateral reduction mammoplasties (breast reductions) performed&#xD;
             less than 2 years prior to enrollment to this study.&#xD;
&#xD;
          -  Subjects undergoing breast conserving surgery whose resected specimen (main lump,&#xD;
             shaves, or any other resected tissue) will be evaluated with frozen section after the&#xD;
             Lumicell-guided removal of shaves.&#xD;
&#xD;
          -  Subjects with a history of allergic reaction to Tegaderm&#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>Barbara Smith, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jorge Ferrer, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Lumicell, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jorge Ferrer, PhD</last_name>
    <phone>617-404-1040</phone>
    <email>jmferrer@lumicell.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kate Smith, MPH, CCRP</last_name>
    <phone>617-404-1033</phone>
    <email>kate@lumicell.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford Hospital and Clinics</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irene Wapnir, MD</last_name>
    </contact>
    <investigator>
      <last_name>Irene Wapnir, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Morton Plant Mease Health Care Oncology Research</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Blumencranz</last_name>
    </contact>
    <investigator>
      <last_name>Peter Blumencranz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Smith, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Barbara Smith, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shelley Hwang, MD</last_name>
    </contact>
    <investigator>
      <last_name>Shelley Hwang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Novant Health Cancer Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Carr</last_name>
    </contact>
    <investigator>
      <last_name>David Carr, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Hunt, MD</last_name>
    </contact>
    <investigator>
      <last_name>Kelly Hunt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer surgery</keyword>
  <keyword>lumpectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04440982
org study id: CLP0008
secondary id: 1R01CA212138-01
nct id: NCT04440982
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
This is a prospective, multi-center, randomized, clinical trial evaluating patients
      undergoing breast conserving surgery using the LUM Imaging System.
Detailed Description:

      All subjects will be injected with LUM015. The injection of the study drug will occur 2-6
      hours prior to surgery at a dose of 1.0 mg/kg. For all subjects, surgeons will perform main
      specimen resection per standard of care. For subjects randomized to the intervention arm, the
      surgeon will use the Lum System to scan and image all orientations within the cavity and The
      LUM Imaging System will guide shave removal. Then, for all subjects (control and intervention
      arm), comprehensive shaved margins are removed.

      In this study, the initial cohort is a "training set" with 10 patients receiving neoadjuvant
      therapy to refine the tumor detection algorithm, if needed. After completion of enrollment of
      the initial 10 subjects for algorithm training, the Investigators will then enroll a cohort
      of patients who received neoadjuvant therapy to further evaluate the performance of the LUM
      Imaging System in this important subset of breast cancer patients. Concurrently to the
      enrollment of this cohort, surgeons will also enroll a cohort of patients who did not receive
      neoadjuvant therapy prior to surgery. Patients will be randomized 3:1 to a LUM-assisted
      lumpectomy versus a standard lumpectomy. In both arms, shaved margins will be taken from the
      entire lumpectomy cavity to compare the extent of residual tumor after standard and
      LUM-assisted lumpectomies to evaluate the negative predictive value of the LUM Imaging System
      following neoadjuvant therapy. Only the group of patients randomized to the device
      (intervention) arm will have the LUM Imaging System guide the removal of tissue prior to the
      removal of final comprehensive shaves of the entire cavity.

      Study treatment ends when the surgery is completed. Patients are followed for adverse events
      until their standard of care follow-up visit or after any secondary surgery, whichever is
      longer.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.
primary purpose: Other
masking: Single (Investigator)
masking description: Masking will only be applied until main lumpectomy is removed. At time of randomization, the study arm will be revealed to the study team.
measure: Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy
time frame: 1 month
description: Refining of the previously validated tumor detection algorithm in breast cancer patients receiving neoadjuvant therapy will be conducted in the first cohort and the validation of this algorithm will use data from the second cohort.
measure: Number of patients with reported adverse events
time frame: 14 days
description: Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
measure: Reduction in residual tumor
time frame: 3 months
description: Evaluate reduction in residual tumor left after Lumicell assisted lumpectomy compared with SoC removal of main lumpectomy specimen in patients who have received and not received neo-adjuvant therapy
measure: Report on patient reported outcomes and patient preference information
time frame: 12 months
description: Collect and summarize patient reported information on outcomes and preference
arm group label: Device Intervention: LUM Imaging System used during surgery
arm group type: Experimental
description: The LUM Imaging Device will be used to look inside the lumpectomy cavity to see if the dye indicates any areas that may contain residual tumor. If the imaging identifies that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an additional piece of tissue. This process will be continued until a negative reading from the device is obtained or a maximum of 2 shaves of additional tissue has been removed. Patients in this arm will receive the study drug, LUM015
arm group label: Standard of Care Arm
arm group type: No Intervention
description: The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
intervention type: Combination Product
intervention name: Study Device Arm
description: LUM015 will be administered 2 to 6 hours prior to surgery. The LUM Imaging device will be used to assist in the removal of additional tumor tissue.
arm group label: Device Intervention: LUM Imaging System used during surgery
other name: LUM Imaging System
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barbara Smith, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Jorge Ferrer, PhD
role: Study Director
affiliation: Lumicell, Inc.
last name: Jorge Ferrer, PhD
phone: 617-404-1040
email: jmferrer@lumicell.com
last name: Kate Smith, MPH, CCRP
phone: 617-404-1033
email: kate@lumicell.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No