xml: <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/NCT05990998</url>
    </required_header>
    <id_info>
      <org_study_id>First AHFujian</org_study_id>
      <nct_id>NCT05990998</nct_id>
    </id_info>
    <brief_title>A Head-to-head Comparison of [68Ga]Ga-FAPI and [68Ga]Ga-TATE PET/CT in Patients With Nasopharyngeal Carcinoma: a Single-center, Prospective Study</brief_title>
    <official_title>First Affiliated Hospital of Fujian Medical University</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Both fibroblast activation protein (FAP)-targeted imaging and somatostatin receptors&#xD;
        (SSTR)-targeted imaging were the promising imaging modalities for the diagnosis of primary&#xD;
        and metastatic nasopharyngeal carcinoma (NPC). This prospective study is going to investigate&#xD;
        to compare the diagnostic efficacy of 68Ga-FAPI and 68Ga-DOTATATE in detecting primary and&#xD;
        metastatic NPC lesions, thereby obtaining a more accurate examination method of NPC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with newly diagnosed or previously treated NPC will be recruited in this study.&#xD;
  &#xD;
        Each patient received an intravenous injection of 68Ga-DOTATATE (2-4mCi) on the first day and&#xD;
        68Ga-FAPI (2-4mCi) on the second day. Whole-body PET/CT scans were performed at 40-60 min&#xD;
        after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and&#xD;
        lesion uptake were compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 20, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <phase>Phase 1/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</measure>
      <time_frame>through study completion, an average of 2 years</time_frame>
      <description>Determination of SUV for detected lesions and discernible organs of 68Ga-FAPI and 68Ga-DOTATATE scan.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lesion numbers</measure>
      <time_frame>through study completion, an average of 2 years</time_frame>
      <description>Determination of lesion numbers of 68Ga-FAPI and 68Ga-DOTATATE scan.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Tumor Positron-Emission Tomography</condition>
    <arm_group>
      <arm_group_label>Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>NPC patients receive a single intravenous injection of 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT (2-4mCi) PET/CT,and undergo PET/CT scan at 40-60 min post-injection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>68Ga-DOTATATE and 68Ga-FAPI</intervention_name>
      <description>Each patient receive a single intravenous injection of 68Ga-FAPI or 68Ga-DOTATATE (2-4mCi) , and undergo PET/CT scan at 40-60 min post injection.</description>
      <arm_group_label>Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients of either gender, aged ≥ 18 years.&#xD;
  &#xD;
                 -  Patients with newly diagnosed or previously treated NPC&#xD;
  &#xD;
                 -  A diagnostic magnetic resonance imaging (MRI) of the tumor region within the&#xD;
                    previous 1 weeks prior to dosing day is available.&#xD;
  &#xD;
                 -  signed written consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  breastfeeding&#xD;
  &#xD;
            -  the inability or unwillingness of the research participant, parent or legal&#xD;
               representative to provide written informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Weibing Miao, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital of Fujian Medical University</affiliation>
    </overall_official>
    <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>jieling zheng</last_name>
      <phone>86-599-87981619</phone>
      <email>775304265@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Nuclear Medicine, 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>+86 591 87981618</phone>
        <email>miaoweibing@126.com</email>
      </contact>
      <contact_backup>
        <last_name>Zhenying Chen, MB</last_name>
        <phone>+86 591 87981619</phone>
        <email>714144972@qq.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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 of Nuclear Medicine Department</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990998
  org study id: First AHFujian
  nct id: NCT05990998
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Both fibroblast activation protein (FAP)-targeted imaging and somatostatin receptors
        (SSTR)-targeted imaging were the promising imaging modalities for the diagnosis of primary
        and metastatic nasopharyngeal carcinoma (NPC). This prospective study is going to investigate
        to compare the diagnostic efficacy of 68Ga-FAPI and 68Ga-DOTATATE in detecting primary and
        metastatic NPC lesions, thereby obtaining a more accurate examination method of NPC.
  Patients with newly diagnosed or previously treated NPC will be recruited in this study.
  
        Each patient received an intravenous injection of 68Ga-DOTATATE (2-4mCi) on the first day and
        68Ga-FAPI (2-4mCi) on the second day. Whole-body PET/CT scans were performed at 40-60 min
        after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and
        lesion uptake were compared.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: SUVmax
  time frame: through study completion, an average of 2 years
  description: Determination of SUV for detected lesions and discernible organs of 68Ga-FAPI and 68Ga-DOTATATE scan.
  measure: Lesion numbers
  time frame: through study completion, an average of 2 years
  description: Determination of lesion numbers of 68Ga-FAPI and 68Ga-DOTATATE scan.
  arm group label: Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT
  arm group type: Experimental
  description: NPC patients receive a single intravenous injection of 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT (2-4mCi) PET/CT,and undergo PET/CT scan at 40-60 min post-injection.
  intervention type: Drug
  intervention name: 68Ga-DOTATATE and 68Ga-FAPI
  description: Each patient receive a single intravenous injection of 68Ga-FAPI or 68Ga-DOTATATE (2-4mCi) , and undergo PET/CT scan at 40-60 min post injection.
  arm group label: Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Weibing Miao, M.D.
  role: Principal Investigator
  affiliation: First Affiliated Hospital of Fujian Medical University
  last name: Weibing Miao, MD
  phone: 86-0591-87981618
  email: miaoweibing@126.com
  last name: jieling zheng
  phone: 86-599-87981619
  email: 775304265@qq.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 of Nuclear Medicine Department
  sharing ipd: No