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/NCT05983796</url>
    </required_header>
    <id_info>
      <org_study_id>IIT20230066C</org_study_id>
      <nct_id>NCT05983796</nct_id>
    </id_info>
    <brief_title>18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.</brief_title>
    <official_title>Prospective Study of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital of Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Zhejiang 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>
        This is a open-label, one-arm, multicenter study aimed to explore the efficacy and safety of&#xD;
        18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma</measure>
      <time_frame>up to 2 years</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>18F-HER2 PET</condition>
    <arm_group>
      <arm_group_label>18F-HER2 PET</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>18F-HER2 PET</intervention_name>
      <description>18F-HER2 PET</description>
      <arm_group_label>18F-HER2 PET</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Informed consent document must be signed.&#xD;
  &#xD;
            2. Aged 30-80 years old, both genders.&#xD;
  &#xD;
            3. Patients with locally advanced or advanced urothelial carcinoma&#xD;
  &#xD;
            4. Patients plan to undergo anti HER2 treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with active malignancies other than urothelial carcinoma within 5 years&#xD;
               should be excluded.&#xD;
  &#xD;
            2. Patients with severe liver, kidney, and hematopoietic diseases&#xD;
  &#xD;
            3. Patients with other mental disorders or primary emotional disorders&#xD;
  &#xD;
            4. Those who are unable to understand, comply with the research protocol, or sign an&#xD;
               informed consent form&#xD;
  &#xD;
            5. PET imaging Contraindication (including pregnant women, lactating women, women of&#xD;
               childbearing age who have a recent fertility plan, etc.)&#xD;
  &#xD;
            6. Individuals who are allergic to imaging agents&#xD;
  &#xD;
            7. Hypoglycemic reactions, severe pain, etc. cannot be accompanied by PET scans&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jianzhen Shan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zhejiang University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>The First Affiliated Hospital, Zhejiang University School of medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310009</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 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, Transitional Cell</mesh_term>
    </condition_browse>
    <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/NCT05983796
  org study id: IIT20230066C
  nct id: NCT05983796
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a open-label, one-arm, multicenter study aimed to explore the efficacy and safety of
        18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma
  time frame: up to 2 years
  arm group label: 18F-HER2 PET
  arm group type: Experimental
  intervention type: Diagnostic Test
  intervention name: 18F-HER2 PET
  description: 18F-HER2 PET
  arm group label: 18F-HER2 PET
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jianzhen Shan
  role: Principal Investigator
  affiliation: Zhejiang University
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma, Transitional Cell
  sharing ipd: No