<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/NCT04460495</url>
  </required_header>
  <id_info>
    <org_study_id>20-000449</org_study_id>
    <secondary_id>NCI-2020-03446</secondary_id>
    <nct_id>NCT04460495</nct_id>
  </id_info>
  <brief_title>Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI</brief_title>
  <official_title>Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial looks to study the safety and feasibility of using oxygen-enhanced molecular MRI&#xD;
      to understand how cancer cells use oxygen differently than normal cells. Cancer cells tend to&#xD;
      utilize (or not utilize) oxygen differently than normal cells. By using the oxygen-enhanced&#xD;
      molecular MRI, researchers will be able to create spatial &quot;maps&quot; depicting areas of abnormal&#xD;
      oxygen utilization unique to cancer. This type of information may be useful for diagnosing&#xD;
      new cancers, understanding various &quot;subtypes&quot; of cancer that might utilize oxygen&#xD;
      differently, or this information may be useful for evaluating new drugs that impact cancer&#xD;
      metabolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the safety, feasibility, and sensitivity of oxygen-enhanced molecular magnetic&#xD;
      resonance imaging (MRI) in healthy volunteers.&#xD;
&#xD;
      II. Measure oxygen-enhanced molecular MRI characteristics in human brain tumors.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants undergo arterial spin labeling (ASL) MRI scan and amine chemical exchange&#xD;
      saturation transfer spin-and-gradient echo echo-planar imaging using amine proton CEST echo&#xD;
      spin-and-gradient echo (SAGE) EPI (CEST-SAGE-EPI) while breathing normal room air (21%&#xD;
      oxygen). Patients then undergo another ASL MRI and CEST-SAGE-EPI while breathing medical&#xD;
      grade air (100% oxygen). Total ASL MRI and CEST-SAGE-EPI imaging scan time is 60 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient accrual&#xD;
  </why_stopped>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">September 16, 2021</completion_date>
  <primary_completion_date type="Actual">September 16, 2021</primary_completion_date>
  <phase>N/A</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>oxygen-enhanced molecular MRI in healthy volunteers.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment</measure>
    <time_frame>Baseline and two hours after Oxygen enrichment</time_frame>
    <description>Will be measured by voxel-wise t-tests via analysis of functional NeuroImages (AFNI) software between the average R2' and MTRasym during normal room air and medical grade air.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment</measure>
    <time_frame>Baseline and two hours after Oxygen enrichment</time_frame>
    <description>We will perform voxel-wise t-tests via AFNI software between the average R2' and MTRasym during normal room air and medical grade air.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL).</measure>
    <time_frame>Baseline and two hours after Oxygen enrichment</time_frame>
    <description>Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Malignant Brain Neoplasm</condition>
  <arm_group>
    <arm_group_label>Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergo ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI , while breathing normal room air (21% oxygen). Patients then undergo another ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI imaging scan time is 60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arterial Spin Labeling Magnetic Resonance Imaging</intervention_name>
    <description>Undergo ASL scan</description>
    <arm_group_label>Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)</arm_group_label>
    <other_name>ARTERIAL SPIN LABELING FUNCTIONAL MRI</other_name>
    <other_name>Arterial Spin Labeling MRI</other_name>
    <other_name>ASL</other_name>
    <other_name>ASL fMRI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pH-Weighted amine CEST</intervention_name>
    <description>Undergo pH Weighted amine CEST</description>
    <arm_group_label>Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)</arm_group_label>
    <other_name>Amine CEST</other_name>
    <other_name>CEST-EPI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oxygen-weighted SAGE-EPI</intervention_name>
    <description>Undergo Oxygen-weighted SAGE-EPI</description>
    <arm_group_label>Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)</arm_group_label>
    <other_name>SAGE-EPI</other_name>
    <other_name>Hypoxia MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers will include persons who at the time of scans do not present with&#xD;
             known neurological conditions that might impact tissue imaging results&#xD;
&#xD;
          -  Patient participants should have suspected or pathology-confirmed diagnosis of a brain&#xD;
             tumor (any histological subtype including brain metastases)&#xD;
&#xD;
          -  All participants must be able to obtain an MRI scan and must be able to safely breathe&#xD;
             high concentrations of oxygen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with contraindications to MRI including metal implants&#xD;
&#xD;
          -  Participants who are deemed not able to or not safe to breath high concentrations of&#xD;
             oxygen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin M Ellingson</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</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>Brain Neoplasms</mesh_term>
  </condition_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/NCT04460495
org study id: 20-000449
secondary id: NCI-2020-03446
nct id: NCT04460495
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This trial looks to study the safety and feasibility of using oxygen-enhanced molecular MRI
      to understand how cancer cells use oxygen differently than normal cells. Cancer cells tend to
      utilize (or not utilize) oxygen differently than normal cells. By using the oxygen-enhanced
      molecular MRI, researchers will be able to create spatial "maps" depicting areas of abnormal
      oxygen utilization unique to cancer. This type of information may be useful for diagnosing
      new cancers, understanding various "subtypes" of cancer that might utilize oxygen
      differently, or this information may be useful for evaluating new drugs that impact cancer
      metabolism.
PRIMARY OBJECTIVES:

      I. Determine the safety, feasibility, and sensitivity of oxygen-enhanced molecular magnetic
      resonance imaging (MRI) in healthy volunteers.

      II. Measure oxygen-enhanced molecular MRI characteristics in human brain tumors.

      OUTLINE:

      Participants undergo arterial spin labeling (ASL) MRI scan and amine chemical exchange
      saturation transfer spin-and-gradient echo echo-planar imaging using amine proton CEST echo
      spin-and-gradient echo (SAGE) EPI (CEST-SAGE-EPI) while breathing normal room air (21%
      oxygen). Patients then undergo another ASL MRI and CEST-SAGE-EPI while breathing medical
      grade air (100% oxygen). Total ASL MRI and CEST-SAGE-EPI imaging scan time is 60 minutes.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: oxygen-enhanced molecular MRI in healthy volunteers.
primary purpose: Other
masking: None (Open Label)
measure: Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment
time frame: Baseline and two hours after Oxygen enrichment
description: Will be measured by voxel-wise t-tests via analysis of functional NeuroImages (AFNI) software between the average R2' and MTRasym during normal room air and medical grade air.
measure: Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment
time frame: Baseline and two hours after Oxygen enrichment
description: We will perform voxel-wise t-tests via AFNI software between the average R2' and MTRasym during normal room air and medical grade air.
measure: Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL).
time frame: Baseline and two hours after Oxygen enrichment
description: Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment
arm group label: Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)
arm group type: Experimental
description: Participants undergo ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI , while breathing normal room air (21% oxygen). Patients then undergo another ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI imaging scan time is 60 minutes.
intervention type: Procedure
intervention name: Arterial Spin Labeling Magnetic Resonance Imaging
description: Undergo ASL scan
arm group label: Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)
other name: ARTERIAL SPIN LABELING FUNCTIONAL MRI
other name: Arterial Spin Labeling MRI
other name: ASL
other name: ASL fMRI
intervention type: Procedure
intervention name: pH-Weighted amine CEST
description: Undergo pH Weighted amine CEST
arm group label: Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)
other name: Amine CEST
other name: CEST-EPI
intervention type: Procedure
intervention name: Oxygen-weighted SAGE-EPI
description: Undergo Oxygen-weighted SAGE-EPI
arm group label: Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)
other name: SAGE-EPI
other name: Hypoxia MRI
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin M Ellingson
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Neoplasms