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/NCT06014905</url>
    </required_header>
    <id_info>
      <org_study_id>23924</org_study_id>
      <secondary_id>NCI-2023-05550</secondary_id>
      <secondary_id>5R21EB030899-02</secondary_id>
      <nct_id>NCT06014905</nct_id>
    </id_info>
    <brief_title>Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma</brief_title>
    <official_title>Pilot/Phase I Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Javier Villaneuva-Meyer, MD</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>
      <collaborator>
        <agency>General Electric</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</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 is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that&#xD;
        includes the acquisition of magnetic resonance (MR) data performed on participants with&#xD;
        meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive&#xD;
        tumor behavior&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objective:&#xD;
  &#xD;
        I. To assess the feasibility of hyperpolarized 13C MR imaging as a new and unique tool in the&#xD;
        characterization of aggressive tumor behavior in participants with meningioma.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
        I. To define the most appropriate parameters for obtaining hyperpolarized 13C data from&#xD;
        meningioma patients with a run-in study to optimize spatial and temporal resolution and&#xD;
        coverage by detecting signal amplitudes and time dynamics.&#xD;
  &#xD;
        II. To measure tumor pyruvate-to-lactate, pyruvate-to-alanine, and pyruvate-to-bicarbonate&#xD;
        conversion by 13C pyruvate MR imaging in participants with meningioma planning to undergo&#xD;
        surgical resection within 4 weeks, using parameters.&#xD;
  &#xD;
        Outline:&#xD;
  &#xD;
        Participants will receive a single imaging procedure using HP 13C pyruvate. Participants will&#xD;
        then be followed-up for 30 days after completion of the study or until voluntary withdrawal&#xD;
        or death.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>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>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of participants who complete 13C pyruvate MR imaging.</measure>
      <time_frame>Day of MR imaging (1 day)</time_frame>
      <description>All participants who are enrolled in the study and receive any amount of hyperpolarized 13C pyruvate will be included in the primary outcome analysis. The proportion of participants who complete hyperpolarized 13C pyruvate MR imaging will be reported. If the proportion is greater than 0.7, hyperpolarized 13C MR imaging will be determined to be feasible.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Best Magnetic Resonance (MR) imaging protocol (&quot;measurement&quot;) to detect altered pyruvate-to-lactate cell metabolism</measure>
      <time_frame>Day of MR imaging (1 day)</time_frame>
      <description>Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yields the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-lactate will be identified.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best Magnetic Resonance (MR) imaging protocol (&quot;measurement&quot;) to detect altered pyruvate-to-alanine cell metabolism</measure>
      <time_frame>Day of MR imaging (1 day)</time_frame>
      <description>Five initial patients will be evaluated to establish the spatial, temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-alanine will be identified.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best Magnetic Resonance (MR) imaging protocol (&quot;measurement&quot;) to detect altered pyruvate-to-bicarbonate cell conversion</measure>
      <time_frame>Day of MR imaging (1 day)</time_frame>
      <description>Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-bicarbonate conversion will be identified.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean of pyruvate-to-lactate</measure>
      <time_frame>Day of MR imaging (1 day)</time_frame>
      <description>The mean and standard deviations of pyruvate-to-lactate ratio will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean of pyruvate-to-alanine</measure>
      <time_frame>Day of MR imaging (1 day)</time_frame>
      <description>The mean and standard deviations of pyruvate-to-alanine ratio will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean of pyruvate-to-bicarbonate conversion</measure>
      <time_frame>Day of MR imaging (1 day)</time_frame>
      <description>The mean and standard deviations of pyruvate-to-bicarbonate conversion rate will be reported.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Meningioma</condition>
    <arm_group>
      <arm_group_label>Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single research MR imaging using HP 13C pyruvate, intravenously injected at a rate of 5 ml/second followed by a 20-ml saline flush at 5 ml/second. Safety monitoring, including vital signs and symptom monitoring will be performed for 30 minutes after dosing is completed, 1 to 3 days after dosing, and up to 30 days post scanning procedure. During the follow-up period, study personnel will obtain clinical data from the participants' medical records.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hyperpolarized carbon C 13 pyruvate</intervention_name>
      <description>Given Intravenously (IV)</description>
      <arm_group_label>Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging</arm_group_label>
      <other_name>Hyperpolarized 13C-Pyruvate</other_name>
      <other_name>HP C13 pyruvate</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Magnetic Resonance Image (MRI)</intervention_name>
      <description>Imaging procedure</description>
      <arm_group_label>Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging</arm_group_label>
      <other_name>MR</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Saline</intervention_name>
      <description>Given IV</description>
      <arm_group_label>Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging</arm_group_label>
      <other_name>Saline Flush</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Known (histopathologically confirmed) or presumed meningioma based on imaging with&#xD;
               measurable disease on MRI that shows gadolinium enhancement (at least one cm diameter)&#xD;
               intracranially (e.g., not confined to skull base alone).&#xD;
  &#xD;
            2. Participants cannot have contraindication to MRI examinations.&#xD;
  &#xD;
            3. Age &gt;=18 years.&#xD;
  &#xD;
            4. Have a life expectancy of &gt;12 weeks.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) performance status &lt;2 (Karnofsky &gt;60%).&#xD;
  &#xD;
            6. Participants must have adequate renal function (creatinine &lt; 1.5 mg/dL) before&#xD;
               imaging. This test must be performed within 60 days prior to hyperpolarized imaging&#xD;
               scan.&#xD;
  &#xD;
            7. Participants must sign an informed consent indicating that they are aware of the&#xD;
               investigational nature of this study.&#xD;
  &#xD;
            8. Patients must sign an authorization for the release of their protected health&#xD;
               information.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Has any significant medical illnesses that in the investigator's opinion cannot be&#xD;
               adequately controlled with appropriate therapy, would compromise the patient's ability&#xD;
               to participate in this study or any disease that will obscure toxicity or dangerously&#xD;
               impact response to the imaging agent.&#xD;
  &#xD;
            2. Has New York Heart Association (NYHA) Grade II or greater congestive heart failure.&#xD;
  &#xD;
            3. Has history of myocardial infarction or unstable angina within 12 months prior to&#xD;
               study enrollment.&#xD;
  &#xD;
            4. Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥&gt;=90 mmHg) despite&#xD;
               an optimized regimen of antihypertensive medication.&#xD;
  &#xD;
            5. Has a history of any other cancer (except non-melanoma skin cancer or carcinoma&#xD;
               in-situ of the cervix), unless in complete remission and off of all therapy for that&#xD;
               disease for a minimum of 3 years.&#xD;
  &#xD;
            6. Participants must not be pregnant or breast feeding. Women of childbearing potential&#xD;
               are required to obtain a negative pregnancy test within 14 days of Hyperpolarized&#xD;
               Imaging scan. Effective contraception (men and women) must be used in participants of&#xD;
               child-bearing potential.&#xD;
  &#xD;
            7. Participants must be excluded from participating in the study if they are not able to&#xD;
               comply with the study and/or follow-up procedures.&#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>Javier Villanueva-Meyer, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wendy Ma</last_name>
      <phone>(415) 514-4418</phone>
      <email>Wendy.Ma@ucsf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California, San Francisco</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94143</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Wendy Ma</last_name>
        <phone>415-514-4418</phone>
        <email>Wendy.Ma@ucsf.edu</email>
      </contact>
      <contact_backup>
        <phone>877-827-3222</phone>
        <email>cancertrials@ucsf.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Javier Villanueva-Meyer, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
      <investigator_full_name>Javier Villaneuva-Meyer, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Meningioma</mesh_term>
    </condition_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/NCT06014905
  org study id: 23924
  secondary id: NCI-2023-05550
  secondary id: 5R21EB030899-02
  nct id: NCT06014905
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that
        includes the acquisition of magnetic resonance (MR) data performed on participants with
        meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive
        tumor behavior
  Primary Objective:
  
        I. To assess the feasibility of hyperpolarized 13C MR imaging as a new and unique tool in the
        characterization of aggressive tumor behavior in participants with meningioma.
  
        Secondary Objectives:
  
        I. To define the most appropriate parameters for obtaining hyperpolarized 13C data from
        meningioma patients with a run-in study to optimize spatial and temporal resolution and
        coverage by detecting signal amplitudes and time dynamics.
  
        II. To measure tumor pyruvate-to-lactate, pyruvate-to-alanine, and pyruvate-to-bicarbonate
        conversion by 13C pyruvate MR imaging in participants with meningioma planning to undergo
        surgical resection within 4 weeks, using parameters.
  
        Outline:
  
        Participants will receive a single imaging procedure using HP 13C pyruvate. Participants will
        then be followed-up for 30 days after completion of the study or until voluntary withdrawal
        or death.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Proportion of participants who complete 13C pyruvate MR imaging.
  time frame: Day of MR imaging (1 day)
  description: All participants who are enrolled in the study and receive any amount of hyperpolarized 13C pyruvate will be included in the primary outcome analysis. The proportion of participants who complete hyperpolarized 13C pyruvate MR imaging will be reported. If the proportion is greater than 0.7, hyperpolarized 13C MR imaging will be determined to be feasible.
  measure: Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-lactate cell metabolism
  time frame: Day of MR imaging (1 day)
  description: Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yields the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-lactate will be identified.
  measure: Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-alanine cell metabolism
  time frame: Day of MR imaging (1 day)
  description: Five initial patients will be evaluated to establish the spatial, temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-alanine will be identified.
  measure: Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-bicarbonate cell conversion
  time frame: Day of MR imaging (1 day)
  description: Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-bicarbonate conversion will be identified.
  measure: Mean of pyruvate-to-lactate
  time frame: Day of MR imaging (1 day)
  description: The mean and standard deviations of pyruvate-to-lactate ratio will be reported.
  measure: Mean of pyruvate-to-alanine
  time frame: Day of MR imaging (1 day)
  description: The mean and standard deviations of pyruvate-to-alanine ratio will be reported.
  measure: Mean of pyruvate-to-bicarbonate conversion
  time frame: Day of MR imaging (1 day)
  description: The mean and standard deviations of pyruvate-to-bicarbonate conversion rate will be reported.
  arm group label: Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
  arm group type: Experimental
  description: Participants will receive a single research MR imaging using HP 13C pyruvate, intravenously injected at a rate of 5 ml/second followed by a 20-ml saline flush at 5 ml/second. Safety monitoring, including vital signs and symptom monitoring will be performed for 30 minutes after dosing is completed, 1 to 3 days after dosing, and up to 30 days post scanning procedure. During the follow-up period, study personnel will obtain clinical data from the participants' medical records.
  intervention type: Drug
  intervention name: Hyperpolarized carbon C 13 pyruvate
  description: Given Intravenously (IV)
  arm group label: Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
  other name: Hyperpolarized 13C-Pyruvate
  other name: HP C13 pyruvate
  intervention type: Procedure
  intervention name: Magnetic Resonance Image (MRI)
  description: Imaging procedure
  arm group label: Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
  other name: MR
  intervention type: Other
  intervention name: Saline
  description: Given IV
  arm group label: Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging
  other name: Saline Flush
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Javier Villanueva-Meyer, MD
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Wendy Ma
  phone: (415) 514-4418
  email: Wendy.Ma@ucsf.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of California, San Francisco
  investigator full name: Javier Villaneuva-Meyer, MD
  investigator title: Principal Investigator
  mesh term: Meningioma
  sharing ipd: No