xml: <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/NCT06014515</url>
    </required_header>
    <id_info>
      <org_study_id>1921252</org_study_id>
      <secondary_id>1R01EB033435-01</secondary_id>
      <nct_id>NCT06014515</nct_id>
    </id_info>
    <brief_title>Single-tracer Multiparametric PET Imaging</brief_title>
    <official_title>Single-tracer Multiparametric PET Imaging</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Davis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, Davis</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>
        The overarching goal of this project is to develop and evaluate a single-tracer&#xD;
        multiparametric positron emission tomography (PET) imaging solution for simultaneous imaging&#xD;
        of blood flow and glucose metabolism using 18F-fluorodeoxyglucose (FDG) alone. The&#xD;
        investigators working hypothesis is that quantitative blood flow can be extracted from&#xD;
        dynamic 18F-FDG PET data by use of tracer kinetic modeling, in addition to glucose metabolism&#xD;
        that 18F-FDG is conventionally used for.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Blood flow and glucose metabolism are two basic but vital physiological processes that are&#xD;
        often dysregulated in major diseases. The phenomenon of flow-metabolism mismatch (or&#xD;
        coupling) is of broad clinical and research significance. For example, (a) in ischemic&#xD;
        cardiomyopathy, which affects several million people in the United States, myocardial&#xD;
        flow-metabolism mismatch is clinically used for assessing tissue viability to select patients&#xD;
        for surgical revascularization. Decreased blood flow but maintained glucose metabolism&#xD;
        suggests the myocytes are still alive (while hibernating) and thus can benefit from&#xD;
        revascularization; (b) In oncology, altered blood flow and glucose metabolism are closely&#xD;
        related to two hallmarks of cancer - angiogenesis and increased cell metabolism. High&#xD;
        metabolism-to-flow ratio may indicate cancer cells are resistant to therapy; (c) In the&#xD;
        normal brain, cerebral blood flow and glucose metabolism are often coupled with each other&#xD;
        but may become uncoupled in neurodegenerative diseases including Alzheimer's disease. There&#xD;
        are critical interests and broad needs for integrated imaging of blood flow and metabolism in&#xD;
        both clinical and research applications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2033</completion_date>
    <primary_completion_date type="Anticipated">August 2028</primary_completion_date>
    <phase>Early Phase 1</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>
      <intervention_model_description>Participants will undergo two PET/CT scans with two different radiotracers.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood Flow</measure>
      <time_frame>during the procedure</time_frame>
      <description>The primary study endpoint is to evaluate if the blood flow estimated with 18F-FDG is quantitatively equal to the blood flow measured with the flow-dedicated tracer 11C-butanol measured in ml/min/g.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Metabolism change when using Butanol</measure>
      <time_frame>during the procedure</time_frame>
      <description>The secondary endpoint is to assess the changes in metabolism between healthy subjects and patients using Butanol tracer measured in SUV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Metabolism change when using FDG</measure>
      <time_frame>during the procedure</time_frame>
      <description>The secondary endpoint is to assess the changes in metabolism between healthy subjects and patients using FDG tracer measured in SUV</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Healthy Subjects</condition>
    <condition>Cardiovascular Disease</condition>
    <arm_group>
      <arm_group_label>Experimental: PET/CT scans</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each subject will undergo a dynamic 18F-FDG PET/CT scan and a dynamic 11C-butanol PET/CT scan on the EXPLORER total-body PET/CT system</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>18F-FDG</intervention_name>
      <description>Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.</description>
      <arm_group_label>Experimental: PET/CT scans</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>11C-butanol</intervention_name>
      <description>Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.</description>
      <arm_group_label>Experimental: PET/CT scans</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Inclusion Criteria for all research participants:&#xD;
  &#xD;
                 -  Adults (age ≥ 18 years old)&#xD;
  &#xD;
                 -  Ability to understand and willingness to sign an informed consent form&#xD;
  &#xD;
                 -  Ability to adhere to the study visit schedule and other protocol requirements.&#xD;
  &#xD;
                 -  Willing and able to fast for at least 6 hours before and for the duration of the&#xD;
                    scan&#xD;
  &#xD;
                 -  No strenuous exercise for 24 hours prior to being scanned&#xD;
  &#xD;
                 -  Willing to lie on the scanner bed for up to 60 minutes&#xD;
  &#xD;
                 -  Free of active COVID-19 symptoms&#xD;
  &#xD;
            2. Inclusion Criteria for healthy volunteers only:&#xD;
  &#xD;
               • Free of history of cardiovascular, inflammatory, infections or metabolic diseases&#xD;
               that would result in changes in normal tissue perfusion and/or metabolism.&#xD;
  &#xD;
            3. Inclusion Criteria for patients with disease:&#xD;
  &#xD;
                 -  Patients with clinically acute or chronic conditions such as cardiovascular,&#xD;
                    cardiometabolic, or cardiopulmonary diseases, which may include but are not&#xD;
                    limited to ischemic heart disease, myocarditis, arrhythmias, heart failure,&#xD;
                    nonalcoholic fatty liver disease, COVID-related sequala, diabetes, hypertension,&#xD;
                    or renal disease that would result in changes in normal tissue perfusion and/or&#xD;
                    metabolism.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Participants are not eligible if they meet ANY of the following criteria:&#xD;
  &#xD;
            -  Self-reported history of dysphoria or anxiety in closed spaces&#xD;
  &#xD;
            -  Body weight &gt;240 kg due to limitations of the scanner bed&#xD;
  &#xD;
            -  Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test&#xD;
               will be administered prior to start of each PET/CT session for all participants&#xD;
               between 18 to 60 years old who are able to get pregnant, unless documented&#xD;
               hysterectomy or bilateral ovarian removal is available)&#xD;
  &#xD;
            -  Blood glucose greater than 200 as assessed by fingerstick method before injection of&#xD;
               18F-FDG&#xD;
  &#xD;
            -  Concurrent or prior enrollment in a separate research study involving a PET scan&#xD;
               performed within the last 12 months for research purposes only.&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
            -  Any condition that would prevent the understanding or rendering of informed consent.&#xD;
  &#xD;
            -  Any comorbidity that, in the opinion of the investigator, could compromise protocol&#xD;
               objectives.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guobao Wang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Davis</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lynda Painting, BS</last_name>
      <phone>9167319004</phone>
      <email>lpainting@ucdavis.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dana Little, MS</last_name>
      <phone>916-734-7749</phone>
      <email>dalittle@ucdavis.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UC Davis EXPLORER Molecular Imaging Center</name>
        <address>
          <city>Sacramento</city>
          <state>California</state>
          <zip>95816</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lynda Painting, BS</last_name>
        <phone>916-731-9004</phone>
        <email>lpainting@ucdavis.edu</email>
      </contact>
      <contact_backup>
        <last_name>Dana Little, MS</last_name>
        <phone>916-734-7749</phone>
        <email>dalittle@ucdavis.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Guobao Wang, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>total body positron emission tomography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluorodeoxyglucose F18</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014515
  org study id: 1921252
  secondary id: 1R01EB033435-01
  nct id: NCT06014515
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The overarching goal of this project is to develop and evaluate a single-tracer
        multiparametric positron emission tomography (PET) imaging solution for simultaneous imaging
        of blood flow and glucose metabolism using 18F-fluorodeoxyglucose (FDG) alone. The
        investigators working hypothesis is that quantitative blood flow can be extracted from
        dynamic 18F-FDG PET data by use of tracer kinetic modeling, in addition to glucose metabolism
        that 18F-FDG is conventionally used for.
  Blood flow and glucose metabolism are two basic but vital physiological processes that are
        often dysregulated in major diseases. The phenomenon of flow-metabolism mismatch (or
        coupling) is of broad clinical and research significance. For example, (a) in ischemic
        cardiomyopathy, which affects several million people in the United States, myocardial
        flow-metabolism mismatch is clinically used for assessing tissue viability to select patients
        for surgical revascularization. Decreased blood flow but maintained glucose metabolism
        suggests the myocytes are still alive (while hibernating) and thus can benefit from
        revascularization; (b) In oncology, altered blood flow and glucose metabolism are closely
        related to two hallmarks of cancer - angiogenesis and increased cell metabolism. High
        metabolism-to-flow ratio may indicate cancer cells are resistant to therapy; (c) In the
        normal brain, cerebral blood flow and glucose metabolism are often coupled with each other
        but may become uncoupled in neurodegenerative diseases including Alzheimer's disease. There
        are critical interests and broad needs for integrated imaging of blood flow and metabolism in
        both clinical and research applications.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Participants will undergo two PET/CT scans with two different radiotracers.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Blood Flow
  time frame: during the procedure
  description: The primary study endpoint is to evaluate if the blood flow estimated with 18F-FDG is quantitatively equal to the blood flow measured with the flow-dedicated tracer 11C-butanol measured in ml/min/g.
  measure: Metabolism change when using Butanol
  time frame: during the procedure
  description: The secondary endpoint is to assess the changes in metabolism between healthy subjects and patients using Butanol tracer measured in SUV
  measure: Metabolism change when using FDG
  time frame: during the procedure
  description: The secondary endpoint is to assess the changes in metabolism between healthy subjects and patients using FDG tracer measured in SUV
  arm group label: Experimental: PET/CT scans
  arm group type: Experimental
  description: Each subject will undergo a dynamic 18F-FDG PET/CT scan and a dynamic 11C-butanol PET/CT scan on the EXPLORER total-body PET/CT system
  intervention type: Drug
  intervention name: 18F-FDG
  description: Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.
  arm group label: Experimental: PET/CT scans
  intervention type: Drug
  intervention name: 11C-butanol
  description: Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.
  arm group label: Experimental: PET/CT scans
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Guobao Wang, PhD
  role: Principal Investigator
  affiliation: University of California, Davis
  last name: Lynda Painting, BS
  phone: 9167319004
  email: lpainting@ucdavis.edu
  last name: Dana Little, MS
  phone: 916-734-7749
  email: dalittle@ucdavis.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  mesh term: Fluorodeoxyglucose F18
  sharing ipd: No