<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/NCT03039413</url>
  </required_header>
  <id_info>
    <org_study_id>16G.500</org_study_id>
    <nct_id>NCT03039413</nct_id>
  </id_info>
  <brief_title>Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy</brief_title>
  <official_title>Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography&#xD;
      (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing&#xD;
      surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells.&#xD;
      PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC)&#xD;
      as confirmed by postsurgical or biopsy histology.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of&#xD;
      Cu-64-TP3805.&#xD;
&#xD;
      TERTIARY:&#xD;
&#xD;
      I. To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 28, 2016</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Actual">January 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology</measure>
    <time_frame>Up to 4 weeks post-intervention</time_frame>
    <description>For imaging, positive lesions will be deemed those which shall have standard uptake volume of 1.1 or greater. The results shall be correlated with post-surgical histology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value</measure>
    <time_frame>Up to 120 minutes post injection</time_frame>
    <description>The blood clearance time from all subjects shall be averaged with standard error of the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples</measure>
    <time_frame>Up to 120 minutes post injection</time_frame>
    <description>Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Bladder Urothelial Carcinoma</condition>
  <condition>Urothelial Carcinoma</condition>
  <arm_group>
    <arm_group_label>Diagnostic (Copper Cu 64 TP3805 PET/CT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Copper Cu 64 TP3805</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (Copper Cu 64 TP3805 PET/CT)</arm_group_label>
    <other_name>Cu-64-TP3805</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo Cu-64-TP3805 Positron Emission Tomography scan</description>
    <arm_group_label>Diagnostic (Copper Cu 64 TP3805 PET/CT)</arm_group_label>
    <other_name>Medical Imaging</other_name>
    <other_name>PET</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo Cu-64-TP3805 Computed Tomography scan</description>
    <arm_group_label>Diagnostic (Copper Cu 64 TP3805 PET/CT)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>CAT scan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide signed and dated informed consent form&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Must have diagnosis of urothelial cancer&#xD;
&#xD;
          -  Scheduled for extirpative surgery or biopsy of suspected metastatic lesion&#xD;
&#xD;
          -  Women of reproductive potential must have a urine pregnancy test day of injection&#xD;
&#xD;
          -  Men of reproductive potential must use condoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Known allergic reactions to components of the study product(s)&#xD;
&#xD;
          -  Treatment with another investigational drug or other intervention with 24 hours of&#xD;
             injection&#xD;
&#xD;
          -  Must not have had an injection of a radioisotope 24 hours prior to exam&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Madhukar Thakur, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sidney Kimmel Cancer Center at Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sidney Kimmel Cancer Center at Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Copper</mesh_term>
  </intervention_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/NCT03039413
org study id: 16G.500
nct id: NCT03039413
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography
      (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing
      surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells.
      PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial
      cancer.
PRIMARY OBJECTIVES:

      I. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC)
      as confirmed by postsurgical or biopsy histology.

      SECONDARY OBJECTIVES:

      I. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of
      Cu-64-TP3805.

      TERTIARY:

      I. To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
time frame: Up to 4 weeks post-intervention
description: For imaging, positive lesions will be deemed those which shall have standard uptake volume of 1.1 or greater. The results shall be correlated with post-surgical histology
measure: Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
time frame: Up to 120 minutes post injection
description: The blood clearance time from all subjects shall be averaged with standard error of the mean.
measure: Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples
time frame: Up to 120 minutes post injection
description: Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined.
arm group label: Diagnostic (Copper Cu 64 TP3805 PET/CT)
arm group type: Experimental
description: Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later.
intervention type: Drug
intervention name: Copper Cu 64 TP3805
description: Given IV
arm group label: Diagnostic (Copper Cu 64 TP3805 PET/CT)
other name: Cu-64-TP3805
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo Cu-64-TP3805 Positron Emission Tomography scan
arm group label: Diagnostic (Copper Cu 64 TP3805 PET/CT)
other name: Medical Imaging
other name: PET
other name: Positron Emission Tomography Scan
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo Cu-64-TP3805 Computed Tomography scan
arm group label: Diagnostic (Copper Cu 64 TP3805 PET/CT)
other name: CAT
other name: Computerized Axial Tomography
other name: CAT scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Madhukar Thakur, PhD
role: Principal Investigator
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Transitional Cell
mesh term: Copper