<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/NCT03759704</url>
  </required_header>
  <id_info>
    <org_study_id>STU 072017-069</org_study_id>
    <nct_id>NCT03759704</nct_id>
  </id_info>
  <brief_title>Metabolic Characteristics of Sarcoma In Vivo Using HP 13-C Magnetic Resonance Spectroscopic Imaging (MRSI)</brief_title>
  <acronym>HPMSS</acronym>
  <official_title>Investigating Metabolic Characteristics of Musculoskeletal Sarcoma In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</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>
      Investigators will determine whether MRSI using hyperpolarized [1-13C]pyruvate provide useful&#xD;
      information of tumor malignancy in MRI-indeterminate cases. Metabolite maps of hyperpolarized&#xD;
      [1-13C]lactate and H13CO3- produced from hyperpolarized [1-13C]pyruvate will be compared to&#xD;
      the biopsy results of MRI-indeterminate patients and the 13C-maps of age-matched healthy&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A non-randomized, interventional (nontherapeutic), feasibility trial to detect metabolic&#xD;
      changes in participants with musculoskeletal sarcoma using hyperpolarized [1-13C]pyruvate&#xD;
      Magnetic Resonance Spectroscopy Imaging (MRSI). All measured quantities will be tabulated and&#xD;
      the analysis will be descriptive and obervational in nature.&#xD;
&#xD;
      Participants in this study will receive the study drug, hyperpolarized [1-13C]pyruvate, as a&#xD;
      bolus injection during an MRSI of either a soft tissue sarcoma or healthy tissue. After the&#xD;
      study drug injection and MRSI, participants will then receive contrast material, Gadavist,&#xD;
      via injection during continuation the MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants meeting inclusion criteria were found.&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">August 26, 2021</completion_date>
  <primary_completion_date type="Actual">August 26, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The product ratio difference of lactate to bicarbonate in tumor bearing regions from those in the normal-appearing tissue.</measure>
    <time_frame>One day visit with injection during MRSI</time_frame>
    <description>How much metabolic contrast can be detected using hyperpolarized Carbon-13 pyruvate</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Sarcoma, Soft Tissue</condition>
  <arm_group>
    <arm_group_label>Hyperpolarized 13CPyruvate and gadolinium</arm_group_label>
    <description>Injection with hyperpolarized 13CPyruvate followed by gadolinium during MRSI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyperpolarized 13CPyruvate</intervention_name>
    <description>Bolus injection of study drug during MRSI.</description>
    <arm_group_label>Hyperpolarized 13CPyruvate and gadolinium</arm_group_label>
    <other_name>HP Pyruvate injection</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible study participants will be identified by referring physicians from a UT&#xD;
        Southwestern Clinic. A treating physician will discuss the potential research opportunity&#xD;
        with their patient to determine interest in study participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        SARCOMA patients:&#xD;
&#xD;
        - MRI indeterminate solid enhancing lesion in the pelvis or extremity.&#xD;
&#xD;
        ALL subjects:&#xD;
&#xD;
          -  Age 18 through 100 years.&#xD;
&#xD;
          -  Women of child-bearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for&#xD;
             the duration of study participation. Should a woman become pregnant or suspect she is&#xD;
             pregnant while participating in this study, she should inform her treating physician&#xD;
             immediately.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
          -  All races and ethnicities will be included; subjects must be able to read and speak&#xD;
             the English or Spanish language.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        SARCOMA patients:&#xD;
&#xD;
        -Subjects who have had radiotherapy to the indeterminate lesion.&#xD;
&#xD;
        ALL subjects:&#xD;
&#xD;
          -  Subjects who have had chemotherapy within 4 weeks prior to entering the study or those&#xD;
             who have not recovered from adverse events due to agents administered more than 4&#xD;
             weeks earlier.&#xD;
&#xD;
          -  Subjects may not be receiving any other investigational agents.&#xD;
&#xD;
          -  Any contraindication per MRI Screening form including implants contraindicated at 3T,&#xD;
             pacemakers, implantable Cardioverter Defibrillator (ICD), claustrophobia.&#xD;
&#xD;
          -  Metallic foreign bodies in the field of view which may interfere with MRI&#xD;
             acquisitions.&#xD;
&#xD;
          -  Since each subject is receiving a gadolinium based contrast agent intravenously,&#xD;
             additional contraindications would include: eGFR ≤ 30 mL/min/1.73m2, sickle cell&#xD;
             disease, or hemolytic anemia.&#xD;
&#xD;
          -  Uncontrolled psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Subjects must not be pregnant or nursing due to the potential for congenital&#xD;
             abnormalities and the potential of this regimen to harm nursing infants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Advanced Imaging Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>April 11, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 22, 2022</last_update_submitted>
  <last_update_submitted_qc>March 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Jae Mo Park</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Musculoskeletal Sarcoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</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/NCT03759704
org study id: STU 072017-069
nct id: NCT03759704
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Investigators will determine whether MRSI using hyperpolarized [1-13C]pyruvate provide useful
      information of tumor malignancy in MRI-indeterminate cases. Metabolite maps of hyperpolarized
      [1-13C]lactate and H13CO3- produced from hyperpolarized [1-13C]pyruvate will be compared to
      the biopsy results of MRI-indeterminate patients and the 13C-maps of age-matched healthy
      subjects.
A non-randomized, interventional (nontherapeutic), feasibility trial to detect metabolic
      changes in participants with musculoskeletal sarcoma using hyperpolarized [1-13C]pyruvate
      Magnetic Resonance Spectroscopy Imaging (MRSI). All measured quantities will be tabulated and
      the analysis will be descriptive and obervational in nature.

      Participants in this study will receive the study drug, hyperpolarized [1-13C]pyruvate, as a
      bolus injection during an MRSI of either a soft tissue sarcoma or healthy tissue. After the
      study drug injection and MRSI, participants will then receive contrast material, Gadavist,
      via injection during continuation the MRI.
observational model: Case-Only
time perspective: Prospective
measure: The product ratio difference of lactate to bicarbonate in tumor bearing regions from those in the normal-appearing tissue.
time frame: One day visit with injection during MRSI
description: How much metabolic contrast can be detected using hyperpolarized Carbon-13 pyruvate
arm group label: Hyperpolarized 13CPyruvate and gadolinium
description: Injection with hyperpolarized 13CPyruvate followed by gadolinium during MRSI.
intervention type: Drug
intervention name: Hyperpolarized 13CPyruvate
description: Bolus injection of study drug during MRSI.
arm group label: Hyperpolarized 13CPyruvate and gadolinium
other name: HP Pyruvate injection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Jae Mo Park
investigator title: Principal Investigator
mesh term: Sarcoma