<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/NCT03834272</url>
  </required_header>
  <id_info>
    <org_study_id>CLP-00010</org_study_id>
    <nct_id>NCT03834272</nct_id>
  </id_info>
  <brief_title>Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies</brief_title>
  <official_title>Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lumicell, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lumicell, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      The objective of this feasibility study is to assess the initial safety and efficacy of the&#xD;
      LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary&#xD;
      gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of&#xD;
      two parts: (a) a dose escalation phase to select the optimal dose followed by (b) enrollment&#xD;
      of additional patients to develop the tumor detection algorithm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be recruited and screened at a single institution, Massachusetts General&#xD;
      Hospital. All subjects will have an established diagnosis of metastases to the peritoneum&#xD;
      from primary colonic, appendiceal, or ovarian cancer or mesothelioma and are scheduled for&#xD;
      surgical debulking. This study consists of a dose escalation and timepoint evaluation phase&#xD;
      and an evaluation and improvement phase following tumor detection algorithm development.&#xD;
&#xD;
      30 patients will be enrolled into this study. 18 into a dose escalation arm and 12 in the&#xD;
      algorithm development phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Dose Escalation</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology</measure>
    <time_frame>1 Day</time_frame>
    <description>Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with reported adverse events</measure>
    <time_frame>up to 5 weeks post surgery</time_frame>
    <description>Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Peritoneal Metastases</condition>
  <arm_group>
    <arm_group_label>1st Tier Dose Level- LUM Imaging System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 patients will be administered a single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2nd Tier Dose Level- LUM Imaging System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9 patients will be administered a single dose of LUM015 at 1.5 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3rd Tier Dose Level- LUM Imaging System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 patients will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optimal Dose Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>LUM Imaging System</intervention_name>
    <description>Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.</description>
    <arm_group_label>1st Tier Dose Level- LUM Imaging System</arm_group_label>
    <arm_group_label>2nd Tier Dose Level- LUM Imaging System</arm_group_label>
    <arm_group_label>3rd Tier Dose Level- LUM Imaging System</arm_group_label>
    <arm_group_label>Optimal Dose Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have histologically or cytologically confirmed metastases to the&#xD;
             peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to&#xD;
             surgery.&#xD;
&#xD;
          -  Subjects must be scheduled for surgical resection.&#xD;
&#xD;
          -  Age of 18 years or older.&#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 be otherwise healthy except for the diagnosis of cancer, as per the&#xD;
             criteria listed below.&#xD;
&#xD;
          -  Subjects must have normal organ and marrow function as defined as:&#xD;
&#xD;
               -  Leukocytes &gt; 3,000/mcL&#xD;
&#xD;
               -  Absolute neutrophil count &gt; 1,500/mcL&#xD;
&#xD;
               -  Platelets &gt; 100,000/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;
               -  Creatinine within normal institutional limits or creatinine clearance &gt; 60&#xD;
                  mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.&#xD;
&#xD;
          -  Subjects with ECOG performance status of 0 or 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are pregnant or nursing at the time of diagnosis.&#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 30 days of enrollment.&#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; 100 mm Hg; those subjects with known HTN&#xD;
             should be under these values while under pharmaceutical therapy.&#xD;
&#xD;
          -  History of allergic reaction attributed to drugs containing polyethylene glycol (PEG).&#xD;
&#xD;
          -  History of allergic reaction to any oral or intravenous contrast 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.&#xD;
&#xD;
          -  Any subject for whom the investigator feels participation is not in the best interest&#xD;
             of the subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James C Cusack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jorge Ferrer, Ph.D.</last_name>
    <phone>617-4041040</phone>
    <email>jmferrer@lumicell.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kate Smith, MPH, CCRP</last_name>
    <phone>7815918378</phone>
    <phone_ext>7815918378</phone_ext>
    <email>kate@lumicell.com</email>
  </overall_contact_backup>
  <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>James C Cusack, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal Cancer</keyword>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Mesothelioma</keyword>
  <keyword>Peritoneal surface malignancies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Peritoneal 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/NCT03834272
org study id: CLP-00010
nct id: NCT03834272
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
The objective of this feasibility study is to assess the initial safety and efficacy of the
      LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary
      gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of
      two parts: (a) a dose escalation phase to select the optimal dose followed by (b) enrollment
      of additional patients to develop the tumor detection algorithm.
Subjects will be recruited and screened at a single institution, Massachusetts General
      Hospital. All subjects will have an established diagnosis of metastases to the peritoneum
      from primary colonic, appendiceal, or ovarian cancer or mesothelioma and are scheduled for
      surgical debulking. This study consists of a dose escalation and timepoint evaluation phase
      and an evaluation and improvement phase following tumor detection algorithm development.

      30 patients will be enrolled into this study. 18 into a dose escalation arm and 12 in the
      algorithm development phase.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Dose Escalation
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology
time frame: 1 Day
description: Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.
measure: Number of patients with reported adverse events
time frame: up to 5 weeks post surgery
description: Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
arm group label: 1st Tier Dose Level- LUM Imaging System
arm group type: Experimental
description: 3 patients will be administered a single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.
arm group label: 2nd Tier Dose Level- LUM Imaging System
arm group type: Experimental
description: 9 patients will be administered a single dose of LUM015 at 1.5 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.
arm group label: 3rd Tier Dose Level- LUM Imaging System
arm group type: Experimental
description: 6 patients will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.
arm group label: Optimal Dose Arm
arm group type: Experimental
description: 12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data
intervention type: Combination Product
intervention name: LUM Imaging System
description: Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.
arm group label: 1st Tier Dose Level- LUM Imaging System
arm group label: 2nd Tier Dose Level- LUM Imaging System
arm group label: 3rd Tier Dose Level- LUM Imaging System
arm group label: Optimal Dose Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James C Cusack, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Jorge Ferrer, Ph.D.
phone: 617-4041040
email: jmferrer@lumicell.com
last name: Kate Smith, MPH, CCRP
phone: 7815918378
phone ext: 7815918378
email: kate@lumicell.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Peritoneal Neoplasms
sharing ipd: No