<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/NCT04459273</url>
  </required_header>
  <id_info>
    <org_study_id>20-000630</org_study_id>
    <secondary_id>NCI-2020-03766</secondary_id>
    <nct_id>NCT04459273</nct_id>
  </id_info>
  <brief_title>Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers</brief_title>
  <acronym>FAPI PET RDRC</acronym>
  <official_title>PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: 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>
  </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 exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can&#xD;
      determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and&#xD;
      cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be&#xD;
      seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that&#xD;
      surround tumors (cancer associated fibroblasts). The function of FAP is not well understood&#xD;
      but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with&#xD;
      FAPI PET/CT may in the future provide additional information about various cancers.&#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 various malignancies.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission&#xD;
      tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.&#xD;
&#xD;
      II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and&#xD;
      to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-,&#xD;
      FAP-/ FDG-)&#xD;
&#xD;
      EXPERIMENTAL OBJECTIVE:&#xD;
&#xD;
      To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA&#xD;
      (FDOPA), depending on the specific indication in patients who had them available&#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">August 27, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biodistribution of gallium 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 FAP expression in surgically removed or biopsy derived tumor tissue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution</measure>
    <time_frame>up to 2 years</time_frame>
    <description>2. 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>
  <other_outcome>
    <measure>To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers</measure>
    <time_frame>60 minutes after tracer injection</time_frame>
    <description>The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Bladder Carcinoma</condition>
  <condition>Cervical Carcinoma</condition>
  <condition>Cholangiocarcinoma</condition>
  <condition>Hematopoietic and Lymphoid Cell Neoplasm</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Malignant Adrenal Gland Neoplasm</condition>
  <condition>Malignant Brain Neoplasm</condition>
  <condition>Malignant Pleural Neoplasm</condition>
  <condition>Malignant Skin Neoplasm</condition>
  <condition>Malignant Solid Neoplasm</condition>
  <condition>Malignant Testicular Neoplasm</condition>
  <condition>Malignant Thymus Neoplasm</condition>
  <condition>Neuroendocrine Neoplasm</condition>
  <condition>Thyroid Gland Carcinoma</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Cancer of Unknown Primary Site</condition>
  <arm_group>
    <arm_group_label>Basic science (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>Basic science (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>Basic science (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>Basic science (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>Basic science (68GA-FAPI-46 PET/CT)</arm_group_label>
    <other_name>18F-fluorodeoxyglucose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with the following cancer types:&#xD;
&#xD;
               -  Brain cancer&#xD;
&#xD;
               -  Bladder cancer&#xD;
&#xD;
               -  Urothelial cancer&#xD;
&#xD;
               -  Testicular cancer&#xD;
&#xD;
               -  Skin cancer&#xD;
&#xD;
               -  Thyroid cancer&#xD;
&#xD;
               -  Hepatocellular carcinoma&#xD;
&#xD;
               -  Cholangiocarcinoma&#xD;
&#xD;
               -  Thymus cancer&#xD;
&#xD;
               -  Pleural cancer&#xD;
&#xD;
               -  Cervical cancer&#xD;
&#xD;
               -  Adrenal cancer&#xD;
&#xD;
               -  Neuroendocrine tumors&#xD;
&#xD;
               -  Hematologic cancer&#xD;
&#xD;
               -  Cancer of Unkown Primary&#xD;
&#xD;
          -  Patients who are scheduled to undergo surgical resection or tissue biopsy of the&#xD;
             primary tumor and/or metastasis&#xD;
&#xD;
          -  Patients are ≥ 18 years old at the time of the radiotracer administration.&#xD;
&#xD;
          -  Patient can provide written informed consent&#xD;
&#xD;
          -  Patient is able to remain still for duration of imaging procedure (up to one hour)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant or nursing&#xD;
&#xD;
          -  Patients with any new cancer therapy between the baseline 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</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</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 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>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Skin Neoplasms</mesh_term>
    <mesh_term>Testicular Neoplasms</mesh_term>
    <mesh_term>Pleural Neoplasms</mesh_term>
    <mesh_term>Neoplasms, Unknown Primary</mesh_term>
    <mesh_term>Thymus Neoplasms</mesh_term>
    <mesh_term>Adrenal Gland Neoplasms</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/NCT04459273
org study id: 20-000630
secondary id: NCI-2020-03766
nct id: NCT04459273
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can
      determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and
      cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be
      seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that
      surround tumors (cancer associated fibroblasts). The function of FAP is not well understood
      but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with
      FAPI PET/CT may in the future provide additional information about various cancers.
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 various malignancies.

      SECONDARY OBJECTIVES:

      I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission
      tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.

      II. 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-)

      EXPERIMENTAL OBJECTIVE:

      To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA
      (FDOPA), depending on the specific indication in patients who had them available

      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: Basic Science
masking: None (Open Label)
measure: Biodistribution of gallium 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 FAP expression in surgically removed or biopsy derived tumor tissue.
measure: 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
time frame: up to 2 years
description: 2. 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-)
measure: To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers
time frame: 60 minutes after tracer injection
description: The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation.
arm group label: Basic science (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: Basic science (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: Basic science (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: Basic science (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: Basic science (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
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: Carcinoma
mesh term: Neoplasms
mesh term: Cholangiocarcinoma
mesh term: Brain Neoplasms
mesh term: Urinary Bladder Neoplasms
mesh term: Neuroendocrine Tumors
mesh term: Thyroid Neoplasms
mesh term: Skin Neoplasms
mesh term: Testicular Neoplasms
mesh term: Pleural Neoplasms
mesh term: Neoplasms, Unknown Primary
mesh term: Thymus Neoplasms
mesh term: Adrenal Gland Neoplasms
mesh term: Fluorodeoxyglucose F18
mesh term: FAPI-46