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/NCT06005116</url>
    </required_header>
    <id_info>
      <org_study_id>IIT-2022-0239</org_study_id>
      <nct_id>NCT06005116</nct_id>
    </id_info>
    <brief_title>[68Ga] NOTA-SGC8 in the Staging of Bladder Cancer</brief_title>
    <official_title>Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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>
        The goal of this clinical trial is to test the imaging and diagnostic ability of&#xD;
        [68Ga]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions&#xD;
        it aims to answer are:&#xD;
  &#xD;
          -  Tumor specific lighting ability of [68Ga]-NOTA-SGC8 in bladder cancer patients with&#xD;
             different stages.&#xD;
  &#xD;
          -  The safety of [68Ga]-NOTA-SGC8. Participants will be irrigated with [68Ga]-NOTA-SGC8&#xD;
             into the bladder for tumor imaging under PET/MR. The imaging performance of&#xD;
             [68Ga]-NOTA-SGC8 on different stages of bladder tumors will be systematically evaluated&#xD;
             by combining with pathological sections of patients. Urine accumulation and&#xD;
             radioactivity distribution of [68Ga]-NOTA-SGC8 will be measured. The adverse events will&#xD;
             be recorded.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per&#xD;
        person per time according to body weight, no more than 5mCi. The participants will be&#xD;
        instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the&#xD;
        bladder via catheter for 30 minutes to make full contact between the injection and tumor.&#xD;
        After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected&#xD;
        into the bladder to maintain the shape of the bladder.&#xD;
  &#xD;
        To evaluate the efficacy of [68Ga]-NOTA-SGC8 in imaging bladder tumors, the following indexes&#xD;
        will be measured: specific imaging of the tumor area; specific imaging of its target PTK7&#xD;
        receptor protein; distribution in major organs; PET/MR imaging after administration; the&#xD;
        absorbed dose of internal radiation based on the reference human hormone model using OLINDA&#xD;
        software.&#xD;
  &#xD;
        Tumor tissues of patients will be collected, and pathological sections of relevant patients&#xD;
        will be analyzed after surgery. Immunohistochemistry will be used to verify the expression of&#xD;
        PTK7 receptor in corresponding tumors. The association between PTK7 receptor protein and&#xD;
        tumor malignancy, invasion, and stage will be evaluated by molecular imaging results.&#xD;
  &#xD;
        All adverse events will be recorded within 24 hours after the administration of&#xD;
        [68Ga]-NOTA-SGC8. Serious adverse events will be recorded for all subjects within 24 hours to&#xD;
        5 days after intravesical infusion. Blood and urine samples will be collected and the&#xD;
        concentration of 68Ga-NOTA-SGC8 in the blood and urine will be analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Tumor specific lighting ability of [68Ga]-NOTA-SGC8</measure>
      <time_frame>2 year</time_frame>
      <description>Number of patients whose tumors are lightened under PET/MR with [68Ga]-NOTA-SGC8</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8</measure>
      <time_frame>2 year</time_frame>
      <description>Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Staging ability of [68Ga]-NOTA-SGC8</measure>
      <time_frame>2 year</time_frame>
      <description>Accurate staging ability of [68Ga]-NOTA-SGC8 for bladder tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The expression of PTK7 in bladder tumor tissues</measure>
      <time_frame>2 year</time_frame>
      <description>The expression of [68Ga]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Bladder Cancer</condition>
    <arm_group>
      <arm_group_label>Bladder Cancer Patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>[68Ga]-NOTA-SGC8</intervention_name>
      <description>Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.</description>
      <arm_group_label>Bladder Cancer Patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with newly diagnosed or previously diagnosed bladder tumors.&#xD;
  &#xD;
            -  At least one cystoscopy was performed within one month prior to enrollment, and the&#xD;
               clinical diagnosis of bladder tumor was present.&#xD;
  &#xD;
            -  Age &gt; 18 years, &lt; 80 years&#xD;
  &#xD;
            -  Patients voluntarily participate and sign informed consent and are willing and able to&#xD;
               follow protocol requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy, lactation, severe liver and kidney insufficiency and children;&#xD;
  &#xD;
            -  Participants who are allergic to the experimental drug, have an allergic disposition,&#xD;
               or are allergic to multiple drugs.&#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_contact>
      <last_name>Haige Chen</last_name>
      <phone>13801796126</phone>
      <email>kirbyhaige@aliyun.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Renji Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200127</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Haige Chen</last_name>
        <phone>13801796126</phone>
        <email>kirbyhaige@aliyun.com</email>
      </contact>
      <investigator>
        <last_name>Haige Chen</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bladder Cancer</keyword>
    <keyword>[68Ga]-NOTA-SGC8</keyword>
    <keyword>PET/MR</keyword>
    <keyword>Bladder Irrigation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder Neoplasms</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/NCT06005116
  org study id: IIT-2022-0239
  nct id: NCT06005116
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the imaging and diagnostic ability of
        [68Ga]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions
        it aims to answer are:
  
          -  Tumor specific lighting ability of [68Ga]-NOTA-SGC8 in bladder cancer patients with
             different stages.
  
          -  The safety of [68Ga]-NOTA-SGC8. Participants will be irrigated with [68Ga]-NOTA-SGC8
             into the bladder for tumor imaging under PET/MR. The imaging performance of
             [68Ga]-NOTA-SGC8 on different stages of bladder tumors will be systematically evaluated
             by combining with pathological sections of patients. Urine accumulation and
             radioactivity distribution of [68Ga]-NOTA-SGC8 will be measured. The adverse events will
             be recorded.
  Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per
        person per time according to body weight, no more than 5mCi. The participants will be
        instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the
        bladder via catheter for 30 minutes to make full contact between the injection and tumor.
        After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected
        into the bladder to maintain the shape of the bladder.
  
        To evaluate the efficacy of [68Ga]-NOTA-SGC8 in imaging bladder tumors, the following indexes
        will be measured: specific imaging of the tumor area; specific imaging of its target PTK7
        receptor protein; distribution in major organs; PET/MR imaging after administration; the
        absorbed dose of internal radiation based on the reference human hormone model using OLINDA
        software.
  
        Tumor tissues of patients will be collected, and pathological sections of relevant patients
        will be analyzed after surgery. Immunohistochemistry will be used to verify the expression of
        PTK7 receptor in corresponding tumors. The association between PTK7 receptor protein and
        tumor malignancy, invasion, and stage will be evaluated by molecular imaging results.
  
        All adverse events will be recorded within 24 hours after the administration of
        [68Ga]-NOTA-SGC8. Serious adverse events will be recorded for all subjects within 24 hours to
        5 days after intravesical infusion. Blood and urine samples will be collected and the
        concentration of 68Ga-NOTA-SGC8 in the blood and urine will be analyzed.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Tumor specific lighting ability of [68Ga]-NOTA-SGC8
  time frame: 2 year
  description: Number of patients whose tumors are lightened under PET/MR with [68Ga]-NOTA-SGC8
  measure: Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8
  time frame: 2 year
  description: Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation
  measure: Staging ability of [68Ga]-NOTA-SGC8
  time frame: 2 year
  description: Accurate staging ability of [68Ga]-NOTA-SGC8 for bladder tumors
  measure: The expression of PTK7 in bladder tumor tissues
  time frame: 2 year
  description: The expression of [68Ga]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues
  arm group label: Bladder Cancer Patients
  arm group type: Experimental
  intervention type: Radiation
  intervention name: [68Ga]-NOTA-SGC8
  description: Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.
  arm group label: Bladder Cancer Patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Haige Chen
  phone: 13801796126
  email: kirbyhaige@aliyun.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  sharing ipd: No