<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/NCT04416165</url>
  </required_header>
  <id_info>
    <org_study_id>2019-XJS-1130</org_study_id>
    <nct_id>NCT04416165</nct_id>
  </id_info>
  <brief_title>Comparison of FDG and FAPI in Patients With Various Types of Cancer</brief_title>
  <official_title>Comparison of FDG and FAPI in Patients With Various Types of Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Xiamen University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission&#xD;
      tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions&#xD;
      in various types of cancer, compared with 18F-FDG PET/CT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG&#xD;
      PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was&#xD;
      quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity,&#xD;
      positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and&#xD;
      68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 20, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2027</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Subjects with various types of cancer undergo contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SUV</measure>
    <time_frame>30 days</time_frame>
    <description>Standardized uptake value (SUV) of 18F/ 68Ga-DOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic efficacy</measure>
    <time_frame>30 days</time_frame>
    <description>The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Tumor, Solid</condition>
  <condition>Positron-Emission Tomography</condition>
  <condition>Metastasis</condition>
  <arm_group>
    <arm_group_label>Experimental: 68Ga-DOTA-FAPI-04</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT</intervention_name>
    <description>Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.</description>
    <arm_group_label>Experimental: 68Ga-DOTA-FAPI-04</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (i) adult patients (aged 18 years or order); (ii) patients with suspected or newly&#xD;
             diagnosed or previously treated malignant tumors (supporting evidence may include&#xD;
             magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii)&#xD;
             patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans; (iv)&#xD;
             patients who were able to provide informed consent (signed by participant, parent or&#xD;
             legal representative) and assent according to the guidelines of the Clinical Research&#xD;
             Ethics Committee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the&#xD;
             inability or unwillingness of the research participant, parent or legal representative&#xD;
             to provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hua Wu, PhD</last_name>
    <phone>86 0592-2137166</phone>
    <email>wuhua1025@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haojun Chen, PhD</last_name>
    <phone>86 0592-2137166</phone>
    <email>leochen0821@foxmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First affiliated hospital of xiamen university</name>
      <address>
        <city>XiaMen</city>
        <state>Fujian</state>
        <zip>0086-361000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hua Wu, doctor</last_name>
      <phone>18659285282</phone>
      <email>wuhua1025@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 6, 2023</last_update_submitted>
  <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Positron-Emission Tomography</keyword>
  <keyword>Tumor, Solid</keyword>
  <keyword>Diagnosis</keyword>
  <keyword>Metastasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</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/NCT04416165
org study id: 2019-XJS-1130
nct id: NCT04416165
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission
      tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions
      in various types of cancer, compared with 18F-FDG PET/CT.
Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG
      PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was
      quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity,
      positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and
      68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects with various types of cancer undergo contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUV
time frame: 30 days
description: Standardized uptake value (SUV) of 18F/ 68Ga-DOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.
measure: Diagnostic efficacy
time frame: 30 days
description: The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.
arm group label: Experimental: 68Ga-DOTA-FAPI-04
arm group type: Experimental
description: Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.
intervention type: Diagnostic Test
intervention name: 18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT
description: Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.
arm group label: Experimental: 68Ga-DOTA-FAPI-04
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hua Wu, PhD
phone: 86 0592-2137166
email: wuhua1025@163.com
last name: Haojun Chen, PhD
phone: 86 0592-2137166
email: leochen0821@foxmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Fluorodeoxyglucose F18
sharing ipd: No