<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/NCT03275974</url>
  </required_header>
  <id_info>
    <org_study_id>2020-1083</org_study_id>
    <secondary_id>NCI-2017-01543</secondary_id>
    <nct_id>NCT03275974</nct_id>
  </id_info>
  <brief_title>Glutamine PET Imaging Colorectal Cancer</brief_title>
  <official_title>Glutamine PET Imaging of Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer 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>
      The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography&#xD;
      (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer&#xD;
      compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed&#xD;
      tomography (CT) scanning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To establish and validate a 11C-glutamine (11C-Gln) and fluorine F 18 L-glutamate&#xD;
      derivative BAY94-9392 (18F-FSPG) PET image guided gene signature to predict response to&#xD;
      EGFR-targeted therapy in patients with advanced wild-type RAS colorectal cancer (CRC).&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive 11C-glutamine intravenously (IV) and undergo PET imaging over 120 minutes.&#xD;
      Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18&#xD;
      L-glutamate derivative BAY94-9392 IV and also undergo PET imaging over 120 minutes. During&#xD;
      each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 27, 2021</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2024</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>Pet imaging</measure>
    <time_frame>Baseline prior to treatment with anti-EGFR mAb</time_frame>
    <description>Assessed in terms of Standardized Uptake Values (SUVs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG</measure>
    <time_frame>Baseline prior to treatment with anti-EGFR mAb</time_frame>
    <description>The pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG will be determined using compartmental modeling of PET imaging data. Venous samples will be collected over the course of both 11C-Glutamine and 18F-FSPG scans for use in modeling.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in tumor size</measure>
    <time_frame>Baseline prior to treatment with anti-EGFR mAb and every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); through treatment completion, an average of 24 weeks (6 cycles)</time_frame>
    <description>Change in tumor size will be derived from standard-of-care computed tomography (CT) or magnetic resonance imaging (MRI). The tumor size will be reported as either the long-axis diameter or as tumor volume.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gene expression</measure>
    <time_frame>Prior to treatment with anti-EGFR mAb</time_frame>
    <description>Gene expression will be determined using RNA-Seq of archived primary (and if available, metastatic) tissues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); Up to 4 years after treatment</time_frame>
    <description>Progression-free survival is defined as the time from start of therapy to disease progression by RECIST criteria or death for any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 4 years after treatment</time_frame>
    <description>Overall survival is defined as the time from start of treatment to death for any reason.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>RAS Wild Type</condition>
  <condition>Stage IV Colorectal Cancer</condition>
  <condition>Stage IVA Colorectal Cancer</condition>
  <condition>Stage IVB Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive carbon C 11 Glutamine (11C-glutamine) IV and undergo PET imaging over 120 minutes. Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) IV and also undergo PET imaging over 120 minutes. During each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Carbon C 11 Glutamine</intervention_name>
    <description>Given by IV</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluorine F 18 L-glutamate Derivative BAY94-9392</intervention_name>
    <description>Given by IV</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET scan</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Draw</intervention_name>
    <description>Undergo venous blood draws</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age;&#xD;
&#xD;
          -  Pathologically or cytologically confirmed diagnosis of metastatic (Stage IV) RAS&#xD;
             wildtype CRC;&#xD;
&#xD;
          -  Eligible for anti-EGFR monoclonal antibody (mAb) therapy as standard-of-care (SOC),&#xD;
             either as a single agent or in combination with approved SOC therapies or&#xD;
             investigational agents as part of IRB-approved clinical trials;&#xD;
&#xD;
          -  Archived tissue from the CRC primary tumor in sufficient amounts to allow RNA-seq gene&#xD;
             analysis; specimen from metastatic sites are not required but highly preferred;&#xD;
&#xD;
          -  Documented results from (or scheduled to undergo) CT or MRI of the chest, abdomen and&#xD;
             pelvis as a standard-of-care procedure within 28 days of baseline investigational&#xD;
             11C-Gln PET/CT and 18F-FSPG PET/CT;&#xD;
&#xD;
          -  Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;&#xD;
&#xD;
          -  At least one lesion &gt;2 cm in diameter and thus will be measurable according to PET&#xD;
             Response Criteria in Solid Tumors (PERCIST) v1.0 to avoid PET partial volume effects;&#xD;
&#xD;
          -  Ability to provide written informed consent in accordance with institutional policies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other current or previous malignancy within the past 5 years&#xD;
&#xD;
          -  Previous EGFR-directed therapy&#xD;
&#xD;
          -  Body weight ≥ 400 pounds or body habitus or disability that will not permit the&#xD;
             imaging protocol to be performed&#xD;
&#xD;
          -  Pregnant or lactating females&#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>Lesley Flynt</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Allison Cohen</last_name>
    <phone>(713) 794-4324</phone>
    <email>ascohen1@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>Allison Cohen</last_name>
      <phone>713-794-4324</phone>
      <email>ascohen1@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Lesley Flynt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 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>Colorectal 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/NCT03275974
org study id: 2020-1083
secondary id: NCI-2017-01543
nct id: NCT03275974
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography
      (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer
      compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed
      tomography (CT) scanning.
PRIMARY OBJECTIVES:

      I. To establish and validate a 11C-glutamine (11C-Gln) and fluorine F 18 L-glutamate
      derivative BAY94-9392 (18F-FSPG) PET image guided gene signature to predict response to
      EGFR-targeted therapy in patients with advanced wild-type RAS colorectal cancer (CRC).

      OUTLINE:

      Patients receive 11C-glutamine intravenously (IV) and undergo PET imaging over 120 minutes.
      Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18
      L-glutamate derivative BAY94-9392 IV and also undergo PET imaging over 120 minutes. During
      each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pet imaging
time frame: Baseline prior to treatment with anti-EGFR mAb
description: Assessed in terms of Standardized Uptake Values (SUVs)
measure: Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG
time frame: Baseline prior to treatment with anti-EGFR mAb
description: The pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG will be determined using compartmental modeling of PET imaging data. Venous samples will be collected over the course of both 11C-Glutamine and 18F-FSPG scans for use in modeling.
measure: Change in tumor size
time frame: Baseline prior to treatment with anti-EGFR mAb and every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); through treatment completion, an average of 24 weeks (6 cycles)
description: Change in tumor size will be derived from standard-of-care computed tomography (CT) or magnetic resonance imaging (MRI). The tumor size will be reported as either the long-axis diameter or as tumor volume.
measure: Gene expression
time frame: Prior to treatment with anti-EGFR mAb
description: Gene expression will be determined using RNA-Seq of archived primary (and if available, metastatic) tissues.
measure: Progression free survival
time frame: every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); Up to 4 years after treatment
description: Progression-free survival is defined as the time from start of therapy to disease progression by RECIST criteria or death for any reason.
measure: Overall survival
time frame: Up to 4 years after treatment
description: Overall survival is defined as the time from start of treatment to death for any reason.
arm group label: Treatment
arm group type: Experimental
description: Patients receive carbon C 11 Glutamine (11C-glutamine) IV and undergo PET imaging over 120 minutes. Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) IV and also undergo PET imaging over 120 minutes. During each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed.
intervention type: Biological
intervention name: Carbon C 11 Glutamine
description: Given by IV
arm group label: Treatment
intervention type: Biological
intervention name: Fluorine F 18 L-glutamate Derivative BAY94-9392
description: Given by IV
arm group label: Treatment
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET scan
arm group label: Treatment
intervention type: Procedure
intervention name: Blood Draw
description: Undergo venous blood draws
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lesley Flynt
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Allison Cohen
phone: (713) 794-4324
email: ascohen1@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Colorectal Neoplasms