<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/NCT03764137</url>
  </required_header>
  <id_info>
    <org_study_id>300002089</org_study_id>
    <nct_id>NCT03764137</nct_id>
  </id_info>
  <brief_title>Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer</brief_title>
  <acronym>Panitumumab</acronym>
  <official_title>Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      This clinical study will investigate the utility of PET imaging with [89Zr]Panitumumab for&#xD;
      imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node&#xD;
      involvement. If promising, this data will be used to design larger trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not able to enroll any subjects&#xD;
  </why_stopped>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>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>Image Quality</measure>
    <time_frame>12 months</time_frame>
    <description>Diagnostic image quality of [89Zr]Panitumumab PET imaging in patients with newly diagnosed colon cancer with nodal involvement. Standardized Uptake Values (SUVs) will be measured.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Metastatic Colon Cancer</condition>
  <arm_group>
    <arm_group_label>[89Zr]Panitumumab-PET/MRI patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All study patients will receive [89Zr]Panitumumab-PET/MRI imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[89Zr]Panitumumab PET-MRI</intervention_name>
    <description>All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.</description>
    <arm_group_label>[89Zr]Panitumumab-PET/MRI patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 19 years of age.&#xD;
&#xD;
          -  Diagnosis of colon cancer&#xD;
&#xD;
          -  Scheduled to undergo surgical resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to lie still for the imaging study&#xD;
&#xD;
          -  Weight over 350 lbs., due to the scanner bore size&#xD;
&#xD;
          -  Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)&#xD;
&#xD;
          -  Inability to receive Omnipaque (iohexol) iodinated contrast&#xD;
&#xD;
          -  Inability to receive glucagon&#xD;
&#xD;
          -  Inability to receive Eovist (gadoxetate disodium) gadolinium based contrast agent&#xD;
&#xD;
          -  Allergy to contrast imaging agents&#xD;
&#xD;
          -  Finding or suspicion of distant metastases on CT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Lapi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB Advanced Imaging Facility</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Suzanne E. Lapi, PhD</investigator_full_name>
    <investigator_title>Director Cyclotron Facility</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panitumumab</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/NCT03764137
org study id: 300002089
nct id: NCT03764137
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This clinical study will investigate the utility of PET imaging with [89Zr]Panitumumab for
      imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node
      involvement. If promising, this data will be used to design larger trials.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Image Quality
time frame: 12 months
description: Diagnostic image quality of [89Zr]Panitumumab PET imaging in patients with newly diagnosed colon cancer with nodal involvement. Standardized Uptake Values (SUVs) will be measured.
arm group label: [89Zr]Panitumumab-PET/MRI patients
arm group type: Experimental
description: All study patients will receive [89Zr]Panitumumab-PET/MRI imaging.
intervention type: Drug
intervention name: [89Zr]Panitumumab PET-MRI
description: All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.
arm group label: [89Zr]Panitumumab-PET/MRI patients
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Suzanne Lapi, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Suzanne E. Lapi, PhD
investigator title: Director Cyclotron Facility
mesh term: Colorectal Neoplasms
mesh term: Panitumumab