<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/NCT04478318</url>
  </required_header>
  <id_info>
    <org_study_id>1506448</org_study_id>
    <secondary_id>CCRD039</secondary_id>
    <nct_id>NCT04478318</nct_id>
  </id_info>
  <brief_title>Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma</brief_title>
  <official_title>Quantitative Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma Undergoing Standard-of-Care FDG-PET/CT for Initial Staging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the minimum scan duration for fluorine-18 positron-emitting radioactive&#xD;
      isotope-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography&#xD;
      (CT) scans performed on a total-body PET/CT scanner that results in non-inferior image&#xD;
      quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner. The subject&#xD;
      population will be patients being staged for lung cancer, lymphoma, or melanoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Minimum scan duration on a total-body PET/CT scanner for quality</measure>
    <time_frame>One imaging visit up to two hours</time_frame>
    <description>To determine the minimum scan duration for 18F-FDG PET/CT scans performed on a total-body PET/CT scanner that results in non-inferior image quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner over 20 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimum scan duration on a total-body PET/CT scanner for tumor recognition</measure>
    <time_frame>One imaging visit up to two hours</time_frame>
    <description>To determine the minimum scan duration for 18F-FDG PET/CT scans performed on a total-body PET/CT scanner that results in non-inferior tumor conspicuity to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner over 20 minutes (with an additional 2 minutes of data used for optimization purposes).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Lung Neoplasm</condition>
  <condition>Lymphoma</condition>
  <condition>Melanoma</condition>
  <condition>Fluorodeoxyglucose</condition>
  <condition>Positron-emission Tomography</condition>
  <arm_group>
    <arm_group_label>uEXPLORER/mCT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient will undergo a scan on a total-body PET/CT scanner (uEXPLORER) and then undergo an additional scan on a conventional PET/CT scanner (mCT). The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mCT/uEXPLORER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient will undergo a scan on a conventional PET/CT scanner (mCT) and then undergo an additional scan on a total-body PET/CT scanner (uEXPLORER) . The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>uEXPLORER/mCT</intervention_name>
    <description>Participants will undergo a total-body PET/CT scan with the uEXPLORER scanner first, followed by a PET/CT scan with the conventional mCT PET/CT scanner.</description>
    <arm_group_label>uEXPLORER/mCT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mCT/uEXPLORER</intervention_name>
    <description>Participants will undergo a PET/CT scan with the conventional mCT PET/CT scanner, followed by a total-body PET/CT scan with the uEXPLORER scanner</description>
    <arm_group_label>mCT/uEXPLORER</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to understand and willingness to sign an informed consent form.&#xD;
&#xD;
          2. Ability to adhere to the study visit schedule and all protocol requirements.&#xD;
&#xD;
          3. Men and women ≥18 years of age.&#xD;
&#xD;
          4. Diagnosis or suspected diagnosis of lung cancer, melanoma or lymphoma.&#xD;
&#xD;
          5. Patients who have been referred for a PET/CT scan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women.&#xD;
&#xD;
          2. Claustrophobia.&#xD;
&#xD;
          3. Any significant medical condition that in the opinion of the investigator would&#xD;
             prevent the subject from participating and/or adhering to study related procedures or&#xD;
             interfere with subject safety.&#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>Lorenzo Nardo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis Department of Radiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 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>Lymphoma</mesh_term>
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Lung 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/NCT04478318
org study id: 1506448
secondary id: CCRD039
nct id: NCT04478318
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To determine the minimum scan duration for fluorine-18 positron-emitting radioactive
      isotope-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography
      (CT) scans performed on a total-body PET/CT scanner that results in non-inferior image
      quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner. The subject
      population will be patients being staged for lung cancer, lymphoma, or melanoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Minimum scan duration on a total-body PET/CT scanner for quality
time frame: One imaging visit up to two hours
description: To determine the minimum scan duration for 18F-FDG PET/CT scans performed on a total-body PET/CT scanner that results in non-inferior image quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner over 20 minutes.
measure: Minimum scan duration on a total-body PET/CT scanner for tumor recognition
time frame: One imaging visit up to two hours
description: To determine the minimum scan duration for 18F-FDG PET/CT scans performed on a total-body PET/CT scanner that results in non-inferior tumor conspicuity to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner over 20 minutes (with an additional 2 minutes of data used for optimization purposes).
arm group label: uEXPLORER/mCT
arm group type: Experimental
description: Each patient will undergo a scan on a total-body PET/CT scanner (uEXPLORER) and then undergo an additional scan on a conventional PET/CT scanner (mCT). The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.
arm group label: mCT/uEXPLORER
arm group type: Experimental
description: Each patient will undergo a scan on a conventional PET/CT scanner (mCT) and then undergo an additional scan on a total-body PET/CT scanner (uEXPLORER) . The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.
intervention type: Device
intervention name: uEXPLORER/mCT
description: Participants will undergo a total-body PET/CT scan with the uEXPLORER scanner first, followed by a PET/CT scan with the conventional mCT PET/CT scanner.
arm group label: uEXPLORER/mCT
intervention type: Device
intervention name: mCT/uEXPLORER
description: Participants will undergo a PET/CT scan with the conventional mCT PET/CT scanner, followed by a total-body PET/CT scan with the uEXPLORER scanner
arm group label: mCT/uEXPLORER
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lorenzo Nardo, MD
role: Principal Investigator
affiliation: UC Davis Department of Radiology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Melanoma
mesh term: Lung Neoplasms
sharing ipd: No