<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/NCT04504110</url>
  </required_header>
  <id_info>
    <org_study_id>FAPIEOC</org_study_id>
    <nct_id>NCT04504110</nct_id>
  </id_info>
  <brief_title>68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings</brief_title>
  <official_title>A Prospective Study to Evaluate 68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of&#xD;
      peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by&#xD;
      significant cancer-associated fibroblasts (CAFs) accumulation. Fibroblast activation protein&#xD;
      (FAP) is a protein that is overexpressed on CAFs and can be non-invasively monitored by a&#xD;
      novel radiotracer called 68Ga-FAPI-04 positron emission tomography/computed tomography&#xD;
      (PET/CT). In this study, we will explore the value of 68Ga-FAPI-04 PET/CT in patients with&#xD;
      epithelial ovarian cancer who are scheduled for surgical intervention. The findings of&#xD;
      68Ga-FAPI-04 PET/CT will also be compared with that of 18F-2-fluoro-2-deoxy-D-glucose&#xD;
      fluorodeoxyglucose (18F-FDG) PET/CT, which is one of the most commonly used modalities in&#xD;
      evaluating EOC, and histological findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with epithelial ovarian cancer who are scheduled for surgical intervention will be&#xD;
      recruited in this study. They will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT&#xD;
      study before the surgery. No tumor-specific treatment is allowed between the scan and&#xD;
      surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal&#xD;
      chemotherapy. Three types of lesions will be marked based on 68Ga-FAPI-04 and 18F-FDG PET/CT&#xD;
      findings, which is FAPI+/FDG-, FAPI-/FAPI+, and FAPI+/FDG+ lesions. The marked lesions will&#xD;
      be explored by the surgeon, resected if possible, and compared with histological results. A&#xD;
      fourth type of lesion will be added into the analysis if that lesion is both FAPI and FAP&#xD;
      negative but is a histological-confirmed positive lesion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <phase>Phase 2</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>SUVmax of positive lesions</measure>
    <time_frame>1 hour after tracer injection</time_frame>
    <description>68Ga-FAPI-04 and 18F-FDG accumulation will be determined using SUVmax</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histological findings</measure>
    <time_frame>60 day after surgery</time_frame>
    <description>The presence of tumor cells on resected specimen will be evaluated by pathologists. The FAP expression will be determined using immunohistochemical staining using anti-FAP antibody (Abcam).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Epithelial Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Epithelial ovarian cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>68Ga-FAPI-04 and 18F-FDG PET/CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT</intervention_name>
    <description>Patients with epithelial ovarian cancer who are scheduled for surgical intervention will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery.</description>
    <arm_group_label>Epithelial ovarian cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent signed&#xD;
&#xD;
          -  EOC patients who are scheduled for surgery. The diagnosis of EOC should be based on&#xD;
             the previous histological results or cytological evaluation combined with a serum&#xD;
             CA-125 to carcinoembryonic antigen ratio&gt;25 to confirm the primary diagnosis and&#xD;
             exclude a nongynecologic cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI-04.&#xD;
&#xD;
          -  Tumor-specific treatment is necessary between the scans and surgery, e.g. adjuvant&#xD;
             chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Any mental condition rendering the patient unable to understand the nature, scope, and&#xD;
             possible consequences of the study, and/or evidence of an uncooperative attitude.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Ovarian cancer is a female-specific tumor entity.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wenjia Zhu, MD</last_name>
    <phone>+86 18614080164</phone>
    <email>zhuwenjia_pumc@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li Huo, MD</last_name>
    <phone>+86 13910801986</phone>
    <email>zhuwenjia_pumc@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yupei Zhao, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</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>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04504110
org study id: FAPIEOC
nct id: NCT04504110
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of
      peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by
      significant cancer-associated fibroblasts (CAFs) accumulation. Fibroblast activation protein
      (FAP) is a protein that is overexpressed on CAFs and can be non-invasively monitored by a
      novel radiotracer called 68Ga-FAPI-04 positron emission tomography/computed tomography
      (PET/CT). In this study, we will explore the value of 68Ga-FAPI-04 PET/CT in patients with
      epithelial ovarian cancer who are scheduled for surgical intervention. The findings of
      68Ga-FAPI-04 PET/CT will also be compared with that of 18F-2-fluoro-2-deoxy-D-glucose
      fluorodeoxyglucose (18F-FDG) PET/CT, which is one of the most commonly used modalities in
      evaluating EOC, and histological findings.
Patients with epithelial ovarian cancer who are scheduled for surgical intervention will be
      recruited in this study. They will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT
      study before the surgery. No tumor-specific treatment is allowed between the scan and
      surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal
      chemotherapy. Three types of lesions will be marked based on 68Ga-FAPI-04 and 18F-FDG PET/CT
      findings, which is FAPI+/FDG-, FAPI-/FAPI+, and FAPI+/FDG+ lesions. The marked lesions will
      be explored by the surgeon, resected if possible, and compared with histological results. A
      fourth type of lesion will be added into the analysis if that lesion is both FAPI and FAP
      negative but is a histological-confirmed positive lesion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUVmax of positive lesions
time frame: 1 hour after tracer injection
description: 68Ga-FAPI-04 and 18F-FDG accumulation will be determined using SUVmax
measure: Histological findings
time frame: 60 day after surgery
description: The presence of tumor cells on resected specimen will be evaluated by pathologists. The FAP expression will be determined using immunohistochemical staining using anti-FAP antibody (Abcam).
arm group label: Epithelial ovarian cancer
arm group type: Experimental
description: 68Ga-FAPI-04 and 18F-FDG PET/CT
intervention type: Diagnostic Test
intervention name: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
description: Patients with epithelial ovarian cancer who are scheduled for surgical intervention will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery.
arm group label: Epithelial ovarian cancer
criteria: 
gender: Female
gender based: Yes
gender description: Ovarian cancer is a female-specific tumor entity.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wenjia Zhu, MD
phone: +86 18614080164
email: zhuwenjia_pumc@163.com
last name: Li Huo, MD
phone: +86 13910801986
email: zhuwenjia_pumc@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Fluorodeoxyglucose F18
sharing ipd: No