<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/NCT04499365</url>
  </required_header>
  <id_info>
    <org_study_id>FirstAHFujian3</org_study_id>
    <nct_id>NCT04499365</nct_id>
  </id_info>
  <brief_title>68Ga-FAPI PET/CT in Patients With Various Types of Cancer</brief_title>
  <official_title>68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Fujian Medical University</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>
      To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission&#xD;
      tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions&#xD;
      in various types of cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 PET/CT either for an&#xD;
      initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum&#xD;
      standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value&#xD;
      (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were&#xD;
      calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Standardized uptake value (SUV)</measure>
    <time_frame>30 days</time_frame>
    <description>Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-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 and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic efficacy</measure>
    <time_frame>30 days</time_frame>
    <description>The positive predictive value (PPV), negative predictive value (NPV)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Tumor</condition>
  <condition>Positron-Emission Tomography</condition>
  <condition>Metastasis</condition>
  <arm_group>
    <arm_group_label>Experimental: 68Ga-DOTA/NOTA-FAPI-04</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga-DOTA/NOTA-FAPI-04</intervention_name>
    <description>Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time.</description>
    <arm_group_label>Experimental: 68Ga-DOTA/NOTA-FAPI-04</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PET/CT scan</intervention_name>
    <description>PET/CT scan</description>
    <arm_group_label>Experimental: 68Ga-DOTA/NOTA-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 new&#xD;
             diagnosed or previously treated malignant tumors (supporting evidence may include MRI,&#xD;
             CT, tumor markers and pathology report); (iii) patients who had scheduled&#xD;
             68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) patients who were able to provide informed&#xD;
             consent (signed by participant, parent or legal representative) and assent according&#xD;
             to the guidelines of the Clinical Research 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>Weibing Miao, MD</last_name>
    <phone>86-0591-87981618</phone>
    <email>miaoweibing@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shan Zheng, MD</last_name>
    <phone>86-0591-87981619</phone>
    <email>zhengshan1982@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weibing Miao, MD</last_name>
      <phone>86-0591-87981618</phone>
      <email>miaoweibing@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Shan Zheng, MD</last_name>
      <phone>86-0591-87981619</phone>
      <email>zhengshan1982@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 5, 2020</last_update_submitted>
  <last_update_submitted_qc>September 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Fujian Medical University</investigator_affiliation>
    <investigator_full_name>Weibing Miao, PhD</investigator_full_name>
    <investigator_title>Director, Department of Nuclear Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_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/NCT04499365
org study id: FirstAHFujian3
nct id: NCT04499365
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission
      tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions
      in various types of cancer.
Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 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 68Ga-DOTA/NOTA-FAPI-04 PET/CT were
      calculated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Standardized uptake value (SUV)
time frame: 30 days
description: Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-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 and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.
measure: Diagnostic efficacy
time frame: 30 days
description: The positive predictive value (PPV), negative predictive value (NPV)
arm group label: Experimental: 68Ga-DOTA/NOTA-FAPI-04
arm group type: Experimental
description: Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.
intervention type: Drug
intervention name: 68Ga-DOTA/NOTA-FAPI-04
description: Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time.
arm group label: Experimental: 68Ga-DOTA/NOTA-FAPI-04
intervention type: Diagnostic Test
intervention name: PET/CT scan
description: PET/CT scan
arm group label: Experimental: 68Ga-DOTA/NOTA-FAPI-04
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Weibing Miao, MD
phone: 86-0591-87981618
email: miaoweibing@126.com
last name: Shan Zheng, MD
phone: 86-0591-87981619
email: zhengshan1982@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Fujian Medical University
investigator full name: Weibing Miao, PhD
investigator title: Director, Department of Nuclear Medicine
mesh term: Neoplasm Metastasis
sharing ipd: No