<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/NCT03830151</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0902</org_study_id>
    <secondary_id>NCI-2019-00007</secondary_id>
    <secondary_id>2018-0902</secondary_id>
    <nct_id>NCT03830151</nct_id>
  </id_info>
  <brief_title>Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors</brief_title>
  <official_title>Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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 trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in&#xD;
      diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate&#xD;
      before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI)&#xD;
      scan may help researchers better diagnose glioma in patients with brain tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate&#xD;
      (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate&#xD;
      (kpl) values and Ki-67 quantitation in the tumor.&#xD;
&#xD;
      II. To compare kpl values between tumor and normal brain within patient. III. To assess the&#xD;
      association between kpl values and pathology results, including conventional, diffusion,&#xD;
      perfusion, and permeability imaging.&#xD;
&#xD;
      IV. To assess the association between kpl values and magnetic resonance (MR) imaging&#xD;
      findings.&#xD;
&#xD;
      V. To assess the association between kpl values and genomic findings, including methylation,&#xD;
      ribonucleic acid [RNA], and deoxyribonucleic acid [DNA]).&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds&#xD;
      and then undergo an MRSI scan.&#xD;
&#xD;
      After completion of study, patients are followed up for 1 day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <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>Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ki-67 quantitation</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Spearman's rank correlation will be used to assess the association between kpl values and Ki-67 if the samples are assumed to be independent. Otherwise, intraclass correlation coefficient (ICC) of random effects models will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor kpl values</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will compare with normal brain kpl values. Linear mixed models will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Normal brain kpl values</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will compare with tumor kpl values. Linear mixed models will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathology results</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Correlation with kpl values will be determined through generalized linear mixed models.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MR imaging findings</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Correlation with kpl values will be determined through generalized linear mixed models.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genomic findings</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Correlation with kpl values will be determined through generalized linear mixed models.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">13</enrollment>
  <condition>Primary Brain Neoplasm</condition>
  <arm_group>
    <arm_group_label>Diagnostic (carbon C 13 pyruvate, MRSI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyperpolarized Carbon C 13 Pyruvate</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (carbon C 13 pyruvate, MRSI)</arm_group_label>
    <other_name>Hyperpolarized 13C-Pyruvate</other_name>
    <other_name>Hyperpolarized Pyruvate (13C)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Spectroscopic Imaging</intervention_name>
    <description>Undergo MRSI</description>
    <arm_group_label>Diagnostic (carbon C 13 pyruvate, MRSI)</arm_group_label>
    <other_name>1H- Nuclear Magnetic Resonance Spectroscopic Imaging</other_name>
    <other_name>1H-nuclear magnetic resonance spectroscopic imaging</other_name>
    <other_name>Magnetic Resonance Spectroscopy</other_name>
    <other_name>MRS</other_name>
    <other_name>MRS Imaging</other_name>
    <other_name>MRSI</other_name>
    <other_name>Proton Magnetic Resonance Spectroscopic Imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent will be obtained from each participants including healthy&#xD;
             volunteers.&#xD;
&#xD;
          -  Healthy volunteers will not have contra-indications to MR scanning, but will otherwise&#xD;
             not be subject to other selection criteria.&#xD;
&#xD;
          -  All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial&#xD;
&#xD;
          -  Patient is &gt;18 years old, agrees to participate in the clinical study and to complete&#xD;
             all required visits and evaluations. The pediatric population has a different disease&#xD;
             profile from the glioma patients we hope to recruit. To reduce heterogeneity in the&#xD;
             patient population we will not consider patients younger than 18 for this study.&#xD;
&#xD;
          -  Patient is a candidate for cerebral tumor resection with lesion suspected to be or&#xD;
             previously biopsy proven to be a primary brain tumor.&#xD;
&#xD;
          -  Patient is able to understand and give consent to participation in the study.&#xD;
&#xD;
          -  Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI,&#xD;
             within 14 days and preferably with 3 days of the planned procedure) with perfusion,&#xD;
             diffusion and spectroscopic imaging.&#xD;
&#xD;
          -  Patient has a GFR &gt; 60. In patients with moderate renal failure (GFR 30-60), an&#xD;
             alternate injection with 2 times half-dose multihance (gadobenate dimeglumine) or&#xD;
             gadovist (gadobutrol) will be considered, if a contrast exam is deemed clinically&#xD;
             necessary.&#xD;
&#xD;
          -  Specifically for this Study: Patient is willing to give signed informed consent for&#xD;
             C13-Pyruvate MR Spectroscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers will be screened using same process but will otherwise not be&#xD;
             subject to other selection criteria.&#xD;
&#xD;
          -  The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy&#xD;
             could not be safely performed.&#xD;
&#xD;
          -  Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other&#xD;
             conditions that are not MR safe, which include but are not limited to: •&#xD;
             electronically, magnetically, and mechanically activated implants • ferromagnetic or&#xD;
             electronically operated active devices like automatic cardioverter defibrillators and&#xD;
             cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostatic clips in&#xD;
             the central nervous system (CNS) or body • cochlear implants • other pacemakers, e.g.,&#xD;
             for the carotid sinus • insulin pumps and nerve stimulators • non-MR safe lead wires •&#xD;
             prosthetic heart valves (if dehiscence is suspected) • non-ferromagnetic stapedial&#xD;
             implants • pregnancy • claustrophobia that does not readily respond to oral medication&#xD;
&#xD;
          -  Prior brain tumor treatment, including surgical resection, radiation therapy or&#xD;
             chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the&#xD;
             patient from participation. Remote history (&gt; 6month) of non-CNS malignancy in&#xD;
             remission, without evidence of current/ prior brain metastasis, will also not&#xD;
             disqualify patient from participating.&#xD;
&#xD;
          -  History of cardiac arrhythmia&#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>Dawid Schellingerhout</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dawid Schellingerhout</last_name>
    <phone>713-794-5673</phone>
    <email>dawid.schellingerhout@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dawid Schellingerhout</last_name>
      <phone>713-794-5673</phone>
    </contact>
    <investigator>
      <last_name>Dawid Schellingerhout</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</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>
  <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/NCT03830151
org study id: 2018-0902
secondary id: NCI-2019-00007
secondary id: 2018-0902
nct id: NCT03830151
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in
      diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate
      before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI)
      scan may help researchers better diagnose glioma in patients with brain tumors.
PRIMARY OBJECTIVES:

      I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate
      (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.

      SECONDARY OBJECTIVES:

      I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate
      (kpl) values and Ki-67 quantitation in the tumor.

      II. To compare kpl values between tumor and normal brain within patient. III. To assess the
      association between kpl values and pathology results, including conventional, diffusion,
      perfusion, and permeability imaging.

      IV. To assess the association between kpl values and magnetic resonance (MR) imaging
      findings.

      V. To assess the association between kpl values and genomic findings, including methylation,
      ribonucleic acid [RNA], and deoxyribonucleic acid [DNA]).

      OUTLINE:

      Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds
      and then undergo an MRSI scan.

      After completion of study, patients are followed up for 1 day.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data
time frame: Up to 1 year
description: The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.
measure: Ki-67 quantitation
time frame: Up to 1 year
description: Spearman's rank correlation will be used to assess the association between kpl values and Ki-67 if the samples are assumed to be independent. Otherwise, intraclass correlation coefficient (ICC) of random effects models will be used.
measure: Tumor kpl values
time frame: Up to 1 year
description: Will compare with normal brain kpl values. Linear mixed models will be used.
measure: Normal brain kpl values
time frame: Up to 1 year
description: Will compare with tumor kpl values. Linear mixed models will be used.
measure: Pathology results
time frame: Up to 1 year
description: Correlation with kpl values will be determined through generalized linear mixed models.
measure: MR imaging findings
time frame: Up to 1 year
description: Correlation with kpl values will be determined through generalized linear mixed models.
measure: Genomic findings
time frame: Up to 1 year
description: Correlation with kpl values will be determined through generalized linear mixed models.
arm group label: Diagnostic (carbon C 13 pyruvate, MRSI)
arm group type: Experimental
description: Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
intervention type: Drug
intervention name: Hyperpolarized Carbon C 13 Pyruvate
description: Given IV
arm group label: Diagnostic (carbon C 13 pyruvate, MRSI)
other name: Hyperpolarized 13C-Pyruvate
other name: Hyperpolarized Pyruvate (13C)
intervention type: Procedure
intervention name: Magnetic Resonance Spectroscopic Imaging
description: Undergo MRSI
arm group label: Diagnostic (carbon C 13 pyruvate, MRSI)
other name: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging
other name: 1H-nuclear magnetic resonance spectroscopic imaging
other name: Magnetic Resonance Spectroscopy
other name: MRS
other name: MRS Imaging
other name: MRSI
other name: Proton Magnetic Resonance Spectroscopic Imaging
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Dawid Schellingerhout
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Dawid Schellingerhout
phone: 713-794-5673
email: dawid.schellingerhout@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Brain Neoplasms