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/NCT06033040</url>
    </required_header>
    <id_info>
      <org_study_id>SYSKY-2023-549-01</org_study_id>
      <nct_id>NCT06033040</nct_id>
    </id_info>
    <brief_title>Medical Imaging in Bladder Tumors by MRI</brief_title>
    <official_title>Clinical Study on the Diagnostic and Predictive Value of MRI Multifunctional Imaging in Bladder Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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>
        This study prospectively included 178 patients with bladder neoplastic lesions who planned to&#xD;
        undergo surgery (with or without preoperative neoadjuvant chemotherapy). Inclusion criteria:&#xD;
        Patients with pathologically confirmed bladder cancer after radical or partial cystectomy or&#xD;
        TURBT (&lt; 2 weeks between surgical resection and imaging). Exclusion criteria: 1) Prior&#xD;
        history of chemotherapy and/or radiotherapy; 2) No surgical resection; 3) The interval&#xD;
        between surgical resection and imaging examination is &gt; 2 weeks; 4) Obvious artifacts; 5)MRI&#xD;
        scan contraindications. All subjects underwent pelvic MRI. Data was collected using a Siemens&#xD;
        VIDA 3TMR scanner (Siemens Healthcare, Erlangen, Germany). All subjects underwent&#xD;
        standardized scanning protocols. The obtained images are post-processed and the experimental&#xD;
        results are analyzed statistically.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Month</target_duration>
    <primary_outcome>
      <measure>quantitative parameters by MRI</measure>
      <time_frame>From the time the participants completed the MRI scan to the post-processing of the resulting images,assessed up to 2 months</time_frame>
      <description>quantitative parameters by functional MRI</description>
    </primary_outcome>
    <enrollment type="Anticipated">178</enrollment>
    <condition>Bladder Tumor</condition>
    <condition>Magnetic Resonance Imaging</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>MRI</intervention_name>
      <description>Functional sequence imaging (MDME, IVIM) sequences were added to the routine MRI scan of patients with bladder tumor</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with bladder neoplasm planned to undergo surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Clinical diagnosis of bladder neoplasm&#xD;
  &#xD;
            2. Must undergo radical or partial cystectomy or TURBT surgery within 2 weeks between&#xD;
               surgical resection and imaging&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. A history of pelvic radiotherapy or chemotherapy;&#xD;
  &#xD;
            2. Lack of pathological findings or no surgery;&#xD;
  &#xD;
            3. The interval between surgical resection and imaging examination &gt; 2 weeks;&#xD;
  &#xD;
            4. Poor image quality due to poor coordination or motion artifacts;&#xD;
  &#xD;
            5. MRI scan contraindications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Yuan Luo, master</last_name>
      <phone>8618816791193</phone>
      <email>luoy289@mail2.sysu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen Memorial Hospital, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guang Dong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuan Luo</last_name>
        <phone>18816791193</phone>
        <email>luoy289@mail2.sysu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Urinary Bladder Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06033040
  org study id: SYSKY-2023-549-01
  nct id: NCT06033040
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study prospectively included 178 patients with bladder neoplastic lesions who planned to
        undergo surgery (with or without preoperative neoadjuvant chemotherapy). Inclusion criteria:
        Patients with pathologically confirmed bladder cancer after radical or partial cystectomy or
        TURBT (< 2 weeks between surgical resection and imaging). Exclusion criteria: 1) Prior
        history of chemotherapy and/or radiotherapy; 2) No surgical resection; 3) The interval
        between surgical resection and imaging examination is > 2 weeks; 4) Obvious artifacts; 5)MRI
        scan contraindications. All subjects underwent pelvic MRI. Data was collected using a Siemens
        VIDA 3TMR scanner (Siemens Healthcare, Erlangen, Germany). All subjects underwent
        standardized scanning protocols. The obtained images are post-processed and the experimental
        results are analyzed statistically.
  observational model: Case-Only
  time perspective: Prospective
  measure: quantitative parameters by MRI
  time frame: From the time the participants completed the MRI scan to the post-processing of the resulting images,assessed up to 2 months
  description: quantitative parameters by functional MRI
  intervention type: Other
  intervention name: MRI
  description: Functional sequence imaging (MDME, IVIM) sequences were added to the routine MRI scan of patients with bladder tumor
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Yuan Luo, master
  phone: 8618816791193
  email: luoy289@mail2.sysu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms