<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/NCT04457258</url>
  </required_header>
  <id_info>
    <org_study_id>20-000623</org_study_id>
    <secondary_id>NCI-2020-03767</secondary_id>
    <secondary_id>20-000623</secondary_id>
    <nct_id>NCT04457258</nct_id>
  </id_info>
  <brief_title>68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma</brief_title>
  <official_title>PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Sarcoma: An Exploratory Biodistribution Study With Histopathology Validation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive 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>Jonsson Comprehensive 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This early phase I trial studies an imaging technique called 68Ga-FAPi-46 PET/CT to determine&#xD;
      where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer&#xD;
      tissues in patients with sarcoma. PET is an established imaging technique that utilizes small&#xD;
      amounts of radioactivity attached to very minimal amounts of tracer, in the case of this&#xD;
      research, 68Ga-FAPi. Because some cancers take up 68Ga-FAPi it can be seen with PET. CT&#xD;
      utilizes x-rays that traverse body from the outside. CT images provide an exact outline of&#xD;
      organs and potential inflammatory tissue where it occurs in patient's body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor&#xD;
      (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with sarcoma with&#xD;
      histopathology validation.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate whether 68Ga-FAPi-46 accumulation observed by positron emission tomography&#xD;
      (PET) reflects geography, extent and degree of FAP expression determined by&#xD;
      immuno-histochemistry (IHC).&#xD;
&#xD;
      II. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18&#xD;
      (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP&#xD;
      positive [+]/ FDG+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-).&#xD;
&#xD;
      III. 3. To determine FAP expression profile and identify activating and loss of function&#xD;
      mutations and gene rearrangement in available tumor tissue samples from patients with&#xD;
      localized or metastatic sarcoma using RNA sequencing&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography&#xD;
      (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo&#xD;
      PET/computed tomography (CT) according to standard of care procedures (if applicable).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Anticipated">July 21, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
  <phase>Early 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>Biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues</measure>
    <time_frame>At 20-90 minutes after injection</time_frame>
    <description>Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)</measure>
    <time_frame>Up to year 2</time_frame>
    <description>Will be correlated with and validated by FAP expression in surgically removed or biopsy derived tumor tissue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of the following phenotypes (FAP positive [+]/ fludeoxyglucose [FDG]+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-)</measure>
    <time_frame>Up to year 2</time_frame>
    <description>To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Metastatic Sarcoma</condition>
  <condition>Recurrent Sarcoma</condition>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>Diagnostic (68Ga-FAPI-46 PET/CT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo PET/CT</description>
    <arm_group_label>Diagnostic (68Ga-FAPI-46 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>Gallium Ga 68 FAPi-46</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (68Ga-FAPI-46 PET/CT)</arm_group_label>
    <other_name>68Ga-FAPi-46</other_name>
    <other_name>Gallium-68-FAPi-46</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 (68Ga-FAPI-46 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>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>18F-FDG</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (68Ga-FAPI-46 PET/CT)</arm_group_label>
    <other_name>18F-fluorodeoxyglucose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are scheduled to undergo surgical excision or biopsy of a suspected&#xD;
             sarcoma primary, or a suspected recurrent or metastatic lesion.&#xD;
&#xD;
          -  Patients who are ≥ 18 years old at the time of the radiotracer administration.&#xD;
&#xD;
          -  Patients who can provide written informed consent.&#xD;
&#xD;
          -  Patients who are able to remain still for duration of imaging procedures (up to one&#xD;
             hour for each).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant or nursing.&#xD;
&#xD;
          -  Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the&#xD;
             investigational FAPI PET/CT&#xD;
&#xD;
          -  Patient has underlying disease which, based on the judgment of the investigator, might&#xD;
             interfere with the collection of high quality data.&#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>Jeremie Calais, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrea Limon</last_name>
    <phone>310-206-7372</phone>
    <email>AndreaLimon@mednet.ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ethan Lam</last_name>
    <phone>310-206-7372</phone>
    <email>eclam@mednet.ucla.edu</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Limon</last_name>
      <phone>310-206-7372</phone>
      <email>AndreaLimon@mednet.ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ethan Lam</last_name>
      <phone>310-206-7372</phone>
      <email>eclam@mednet.ucla.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jeremie Calais, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 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>Sarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
    <mesh_term>FAPI-46</mesh_term>
  </intervention_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/NCT04457258
org study id: 20-000623
secondary id: NCI-2020-03767
secondary id: 20-000623
nct id: NCT04457258
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This early phase I trial studies an imaging technique called 68Ga-FAPi-46 PET/CT to determine
      where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer
      tissues in patients with sarcoma. PET is an established imaging technique that utilizes small
      amounts of radioactivity attached to very minimal amounts of tracer, in the case of this
      research, 68Ga-FAPi. Because some cancers take up 68Ga-FAPi it can be seen with PET. CT
      utilizes x-rays that traverse body from the outside. CT images provide an exact outline of
      organs and potential inflammatory tissue where it occurs in patient's body.
PRIMARY OBJECTIVE:

      I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor
      (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with sarcoma with
      histopathology validation.

      SECONDARY OBJECTIVES:

      I. To evaluate whether 68Ga-FAPi-46 accumulation observed by positron emission tomography
      (PET) reflects geography, extent and degree of FAP expression determined by
      immuno-histochemistry (IHC).

      II. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18
      (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP
      positive [+]/ FDG+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-).

      III. 3. To determine FAP expression profile and identify activating and loss of function
      mutations and gene rearrangement in available tumor tissue samples from patients with
      localized or metastatic sarcoma using RNA sequencing

      OUTLINE:

      Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography
      (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo
      PET/computed tomography (CT) according to standard of care procedures (if applicable).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues
time frame: At 20-90 minutes after injection
description: Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).
measure: 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)
time frame: Up to year 2
description: Will be correlated with and validated by FAP expression in surgically removed or biopsy derived tumor tissue.
measure: Frequency of the following phenotypes (FAP positive [+]/ fludeoxyglucose [FDG]+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-)
time frame: Up to year 2
description: To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)
arm group label: Diagnostic (68Ga-FAPI-46 PET/CT)
arm group type: Experimental
description: Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo PET/CT
arm group label: Diagnostic (68Ga-FAPI-46 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: Gallium Ga 68 FAPi-46
description: Given IV
arm group label: Diagnostic (68Ga-FAPI-46 PET/CT)
other name: 68Ga-FAPi-46
other name: Gallium-68-FAPi-46
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET/CT
arm group label: Diagnostic (68Ga-FAPI-46 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
intervention type: Radiation
intervention name: 18F-FDG
description: Given IV
arm group label: Diagnostic (68Ga-FAPI-46 PET/CT)
other name: 18F-fluorodeoxyglucose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeremie Calais, MD
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
last name: Andrea Limon
phone: 310-206-7372
email: AndreaLimon@mednet.ucla.edu
last name: Ethan Lam
phone: 310-206-7372
email: eclam@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Fluorodeoxyglucose F18
mesh term: FAPI-46