<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/NCT03824535</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-46607</org_study_id>
    <secondary_id>NCI-2019-00177</secondary_id>
    <secondary_id>LUN0106</secondary_id>
    <secondary_id>IRB-46607</secondary_id>
    <nct_id>NCT03824535</nct_id>
  </id_info>
  <brief_title>18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules</brief_title>
  <official_title>18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrei Iagaru</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canary Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed&#xD;
      tomography (CT) work in diagnosing early lung cancer in patients with lung nodules. PET&#xD;
      imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT&#xD;
      scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping&#xD;
      researchers diagnose early lung cancer in patients with lung nodules.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Comparison of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) accumulation with&#xD;
      fludeoxyglucose F-18 (18F-FDG) accumulation to assess whether&#xD;
      (4S)-4-(3-18F-Fluoropropyl)-L-Glutamate (18F-FSPG)-PET is better at discriminating between&#xD;
      benign and malignant nodules.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To develop and validate early lung cancer detection biomarkers that would directly impact&#xD;
      the growing need to integrate imaging and non-invasive molecular diagnostics for&#xD;
      indeterminate pulmonary nodules and allow physicians to avoid unnecessary invasive procedures&#xD;
      in patients with benign lung disease.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive 18F-FSPG intravenously (IV) and, undergo a PET/CT scan over 30-60 minutes.&#xD;
      Within 24 hours-14 days, patients receive 18F-FDG and undergo a second PET/CT scan over 30-60&#xD;
      minutes.&#xD;
&#xD;
      After completion of study, patients are followed up within 24-72 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</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>Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>18F-FSPG accumulation in lung nodules will be assessed. The observed FSPG specificity will be assessed against a fixed value of 75%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved performance of prediction model for lung nodules</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Improved performance is defined as a p &lt; 0.05 increase in the C statistic determined using DeLong test for correlated receiver operating characteristic (ROC) curves.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cigarette Smoker</condition>
  <condition>Current Smoker</condition>
  <condition>Former Smoker</condition>
  <condition>Multiple Pulmonary Nodules</condition>
  <condition>Pulmonary Nodule</condition>
  <arm_group>
    <arm_group_label>Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 18F-FSPG IV and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG IV and undergo a second PET/CT scan over 30-60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo PET/CT</description>
    <arm_group_label>Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>CAT Scan</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>computerized tomography</other_name>
    <other_name>CT</other_name>
    <other_name>CT SCAN</other_name>
    <other_name>tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludeoxyglucose F-18</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)</arm_group_label>
    <other_name>18-FDG</other_name>
    <other_name>FDG</other_name>
    <other_name>fludeoxyglucose F 18</other_name>
    <other_name>Fludeoxyglucose F18</other_name>
    <other_name>Fluorine-18 2-Fluoro-2-deoxy-D-Glucose</other_name>
    <other_name>Fluorodeoxyglucose F18</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorine F 18 L-glutamate Derivative BAY94-9392</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)</arm_group_label>
    <other_name>(S)-4-(3-18F-fluoropropyl)-L-glutamic Acid</other_name>
    <other_name>18F-FSPG</other_name>
    <other_name>BAY94-9392</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET/CT</description>
    <arm_group_label>Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)</arm_group_label>
    <other_name>Medical Imaging, Positron Emission Tomography</other_name>
    <other_name>PET</other_name>
    <other_name>PET Scan</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
    <other_name>proton magnetic resonance spectroscopic imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pulmonary nodule between the size of 7 to 30 mm. Subjects with multiple nodules may be&#xD;
             eligible if the dominant nodule is 7 to 30 mm&#xD;
&#xD;
          -  Undergoing standard of care 18F-FDG PET imaging (for indeterminate pulmonary nodule)&#xD;
&#xD;
          -  Current or former cigarette smoker, with &gt;= 20 pack years&#xD;
&#xD;
          -  Documented informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or previous diagnosis of lung cancer&#xD;
&#xD;
          -  Cancer diagnosis within the last 5 years&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carina M Aparici</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford Cancer Institute Palo Alto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahima Goel</last_name>
    <phone>650-723-0371</phone>
    <email>mahimag@stanford.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford Cancer Institute Palo Alto</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahima Goel</last_name>
      <phone>650-723-0371</phone>
      <email>mahimag@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>Carina M Aparici, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Andrei Iagaru</investigator_full_name>
    <investigator_title>Associate Professor of Radiology (Nuclear Medicine)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Pulmonary Nodules</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deoxyglucose</mesh_term>
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
    <mesh_term>Fluorides</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03824535/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03824535
org study id: IRB-46607
secondary id: NCI-2019-00177
secondary id: LUN0106
secondary id: IRB-46607
nct id: NCT03824535
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed
      tomography (CT) work in diagnosing early lung cancer in patients with lung nodules. PET
      imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT
      scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping
      researchers diagnose early lung cancer in patients with lung nodules.
PRIMARY OBJECTIVES:

      I. Comparison of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) accumulation with
      fludeoxyglucose F-18 (18F-FDG) accumulation to assess whether
      (4S)-4-(3-18F-Fluoropropyl)-L-Glutamate (18F-FSPG)-PET is better at discriminating between
      benign and malignant nodules.

      SECONDARY OBJECTIVES:

      I. To develop and validate early lung cancer detection biomarkers that would directly impact
      the growing need to integrate imaging and non-invasive molecular diagnostics for
      indeterminate pulmonary nodules and allow physicians to avoid unnecessary invasive procedures
      in patients with benign lung disease.

      OUTLINE:

      Patients receive 18F-FSPG intravenously (IV) and, undergo a PET/CT scan over 30-60 minutes.
      Within 24 hours-14 days, patients receive 18F-FDG and undergo a second PET/CT scan over 30-60
      minutes.

      After completion of study, patients are followed up within 24-72 hours.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules
time frame: Up to 5 years
description: 18F-FSPG accumulation in lung nodules will be assessed. The observed FSPG specificity will be assessed against a fixed value of 75%.
measure: Improved performance of prediction model for lung nodules
time frame: Up to 5 years
description: Improved performance is defined as a p < 0.05 increase in the C statistic determined using DeLong test for correlated receiver operating characteristic (ROC) curves.
arm group label: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)
arm group type: Experimental
description: Patients receive 18F-FSPG IV and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG IV and undergo a second PET/CT scan over 30-60 minutes.
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo PET/CT
arm group label: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)
other name: CAT
other name: CAT Scan
other name: Computerized Axial Tomography
other name: computerized tomography
other name: CT
other name: CT SCAN
other name: tomography
intervention type: Drug
intervention name: Fludeoxyglucose F-18
description: Given IV
arm group label: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)
other name: 18-FDG
other name: FDG
other name: fludeoxyglucose F 18
other name: Fludeoxyglucose F18
other name: Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
other name: Fluorodeoxyglucose F18
intervention type: Drug
intervention name: Fluorine F 18 L-glutamate Derivative BAY94-9392
description: Given IV
arm group label: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)
other name: (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid
other name: 18F-FSPG
other name: BAY94-9392
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET/CT
arm group label: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)
other name: Medical Imaging, Positron Emission Tomography
other name: PET
other name: PET Scan
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
other name: proton magnetic resonance spectroscopic imaging
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Carina M Aparici
role: Principal Investigator
affiliation: Stanford Cancer Institute Palo Alto
last name: Mahima Goel
phone: 650-723-0371
email: mahimag@stanford.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Stanford University
investigator full name: Andrei Iagaru
investigator title: Associate Professor of Radiology (Nuclear Medicine)
mesh term: Multiple Pulmonary Nodules
mesh term: Deoxyglucose
mesh term: Fluorodeoxyglucose F18
mesh term: Fluorides
sharing ipd: No
provided document: 