<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/NCT03029988</url>
  </required_header>
  <id_info>
    <org_study_id>NAV3-25</org_study_id>
    <secondary_id>1R44CA162783-01</secondary_id>
    <nct_id>NCT03029988</nct_id>
  </id_info>
  <brief_title>An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.</brief_title>
  <official_title>An Exploratory Evaluation of Technetium Tc 99m Tilmanocept by Intravenous (IV) Injection in Subjects With Liver Metastases From Colorectal Carcinoma Patients Using SPECT/CT Imaging Compared to Fluorodeoxyglucose (FDG) PET/CT Imaging.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Navidea Biopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Navidea Biopharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Estimation of the concordance of Tc 99m localization in liver metastases from colorectal&#xD;
      carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, open-label, single-center, comparator study of IV injected Tc 99m&#xD;
      Tilmanocept in the localization and detection of liver metastases in subjects with confirmed&#xD;
      colorectal carcinoma (CRC). The study will be divided into two cohorts.&#xD;
&#xD;
      If it was determined that additional enrollment would not provide meaningful data, for&#xD;
      example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the&#xD;
      subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled&#xD;
      followed by a review of the imaging and safety data.&#xD;
&#xD;
      This study is designed to evaluate the safety and tolerability of Tc 99m tilmanocept&#xD;
      administered intravenously. SPECT/CT imaging of the subject's abdominal cavity will be&#xD;
      reviewed to establish concordance with FDG PET imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of effect in Cohort 1&#xD;
  </why_stopped>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Actual">September 24, 2018</completion_date>
  <primary_completion_date type="Actual">September 24, 2018</primary_completion_date>
  <phase>Phase 1</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>Injection and imaging will begin with Cohort 1. Cohort 1 and Cohort 2 will receive tilmanocept intravenously.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.</measure>
    <time_frame>Within 7 days after Tc 99m tilmanocept administration</time_frame>
    <description>The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Liver Metastases</condition>
  <condition>Colorectal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive 200 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection.&#xD;
If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tilmanocept (Technetium Tc 99m tilmanocept Injection)</intervention_name>
    <description>Drug: Technetium Tc 99m tilmanocept</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <other_name>Lymphoseek</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SPECT/CT Imaging</intervention_name>
    <description>4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject has provided written informed consent with Health Information Portability&#xD;
             and Accountability Act (HIPAA) authorization before the initiation of any&#xD;
             study-related procedures.&#xD;
&#xD;
          -  Subjects must be ≥18 years old;&#xD;
&#xD;
          -  The subject must have a diagnosis of adenocarcinoma of the colon and/or rectum with&#xD;
             FDG PET/CT confirmed metastases to the liver;&#xD;
&#xD;
          -  The subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
             of 0-3;&#xD;
&#xD;
          -  The subject must be at least 4 weeks past any major intraabdominal surgery, including&#xD;
             surgery to the liver;&#xD;
&#xD;
          -  Subjects with prior malignancies other than colon and/or rectum cancer are allowed,&#xD;
             provided they have been treated with curative intent, and have no evidence of&#xD;
             recurrence of that malignancy;&#xD;
&#xD;
          -  Each subject must have no more than 10 qualifying liver lesions that have been&#xD;
             clinically confirmed metastatic adenocarcinoma of the colon by FDG PET/CT imaging.&#xD;
&#xD;
          -  If of childbearing potential, the subject has a negative urine pregnancy test within&#xD;
             48 hours before administration of Tc 99m Tilmanocept, has been surgically sterilized,&#xD;
             or has been postmenopausal for at least 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is pregnant or lactating.&#xD;
&#xD;
          -  The subject has undergone any liver surgery, exclusive of a biopsy.&#xD;
&#xD;
          -  The subject has known sensitivity to dextran.&#xD;
&#xD;
          -  The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy&#xD;
             within the 10 days prior to Tc 99m Tilmanocept administration&#xD;
&#xD;
          -  Before the administration of Tc 99m Tilmanocept, has received any radiopharmaceutical&#xD;
             within 7 radioactive half-lives of that radiopharmaceutical&#xD;
&#xD;
          -  Has received an investigational product within the 30 days prior to Tc 99m Tilmanocept&#xD;
             administration&#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>Frederick O Cope, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Navidea Biopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>September 17, 2019</results_first_submitted>
  <results_first_submitted_qc>October 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 18, 2019</results_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adenocarcinoma, Colorectal Carcinoma, liver metastases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03029988/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1</title>
          <description>Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection.&#xD;
Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept&#xD;
SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </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>
      <population>No subjects enrolled in Cohort 2</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1</title>
          <description>Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection.&#xD;
Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept&#xD;
SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.3" spread="16.80"/>
                  </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="3"/>
                  </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>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.</title>
        <description>The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings.</description>
        <time_frame>Within 7 days after Tc 99m tilmanocept administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - FDG PET CT</title>
            <description>At screening, an FDG PET/CT scan was done in accordance with standard procedures</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 - Tilmanocept SPECT/CT</title>
            <description>Subjects received 50 µg tilmanocept radiolabeled with 2.0 mCi Tc 99m through a single IV injection. SPECT/CT imaging of the abdominal region occurred 4-6 hours post-injection.&#xD;
Note: The liver lesion visualized by FDG PET/CT was excised prior to SPECT/CT imaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.</title>
          <description>The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings.</description>
          <units>Lesions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Liver</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>35 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1</title>
          <description>Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection.&#xD;
Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept&#xD;
SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <description>Subject 25-01-005 experienced an adverse event (AE) of leukocytosis during their Follow-Up Visit laboratory evaluations</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>Subject 25-01-002 reported an AE of hives after the Tc 99m tilmanocept administration (Visit 2, Day 1).</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and make modifications to the publication.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to small number of subjects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Bonnie Abbruzzese Senior Director</name_or_title>
      <organization>Navidea Biopharmaceuticals</organization>
      <phone>614.793.7500 ext 147</phone>
      <email>babbruzzese@navidea.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/NCT03029988
org study id: NAV3-25
secondary id: 1R44CA162783-01
nct id: NCT03029988
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Estimation of the concordance of Tc 99m localization in liver metastases from colorectal
      carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.
This is a prospective, open-label, single-center, comparator study of IV injected Tc 99m
      Tilmanocept in the localization and detection of liver metastases in subjects with confirmed
      colorectal carcinoma (CRC). The study will be divided into two cohorts.

      If it was determined that additional enrollment would not provide meaningful data, for
      example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the
      subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled
      followed by a review of the imaging and safety data.

      This study is designed to evaluate the safety and tolerability of Tc 99m tilmanocept
      administered intravenously. SPECT/CT imaging of the subject's abdominal cavity will be
      reviewed to establish concordance with FDG PET imaging.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Injection and imaging will begin with Cohort 1. Cohort 1 and Cohort 2 will receive tilmanocept intravenously.
primary purpose: Diagnostic
masking: None (Open Label)
masking description: Open Label
measure: Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.
time frame: Within 7 days after Tc 99m tilmanocept administration
description: The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings.
arm group label: Cohort 1
arm group type: Experimental
description: Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection.
arm group label: Cohort 2
arm group type: Experimental
description: Subjects will receive 200 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection.
If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data.
intervention type: Drug
intervention name: Tilmanocept (Technetium Tc 99m tilmanocept Injection)
description: Drug: Technetium Tc 99m tilmanocept
arm group label: Cohort 1
arm group label: Cohort 2
other name: Lymphoseek
intervention type: Procedure
intervention name: SPECT/CT Imaging
description: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.
arm group label: Cohort 1
arm group label: Cohort 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederick O Cope, PhD
role: Principal Investigator
affiliation: Navidea Biopharmaceuticals
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Neoplasm Metastasis
mesh term: Liver Neoplasms
mesh term: Colorectal Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small number of subjects.
point of contact: 