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/NCT06018870</url>
    </required_header>
    <id_info>
      <org_study_id>2023183</org_study_id>
      <nct_id>NCT06018870</nct_id>
    </id_info>
    <brief_title>MRI Contrast Clearance Analysis for Glioma Grading and Genotyping</brief_title>
    <official_title>MRI Contrast Clearance Analysis for Prediction of Grading and Genotyping in Gliomas</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daping Hospital and the Research Institute of Surgery of the Third Military 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>
        Gliomas are the most common primary brain tumor. Gliomas with different grades have different&#xD;
        clinical behaviors that determine treatment planning and patient prognosis in clinical&#xD;
        practice. In the 2021 World Health Organization (WHO) classification of tumors for the&#xD;
        central nervous system, glioma genotyping was considered the most relevant information for&#xD;
        neuroradiologists. The isocitrate dehydrogenase (IDH) genotype and 1p/19q codeletion status&#xD;
        are two essential molecular markers that divide glioma into three groups: IDH wild-type, IDH&#xD;
        mutant with 1p/19q non-codeletion, and IDH mutant with 1p/19q codeletion.&#xD;
  &#xD;
        MRI contrast clearance analysis (CCA) is based on T1 delayed-contrast subtraction map,&#xD;
        Blue/tumor regions in CCA represent efficient clearance of contrast from the tissue (delayed&#xD;
        signal&lt;early signal), while red/nontumor regions in CCA represent contrast accumulation&#xD;
        (delayed signal&gt;early signal).&#xD;
  &#xD;
        However, there are not any reports on the role of MRI CCA in glioma grading and genotyping,&#xD;
        Thus, We hypothesized that the proportion of blue/red region and their histogram analyses,&#xD;
        which could be acquired for predicting IDH genotypes and 1p/19q codeletion in gliomas, and to&#xD;
        assess the application of CCA in glioma grading.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center bidirectional cohort study. The subjects of this study were patients&#xD;
        diagnosed as glioma by pathological biopsy. Patients with suspicious mass will be performed&#xD;
        extra 30 and 60 min after contrast agent application delayed T1-weighted sequences as same as&#xD;
        before. Then enter the next experimental stage. (1) Image format conversion; (2)&#xD;
        Registration;(3) Subtraction;(4) ROI segmentation;(5) ROI histogram analyses. Histogram&#xD;
        parameters of blue and red ROI includes 1st、10th 、90th and 99th percentiles, mean, median,&#xD;
        variance, skewness, and kurtosis.&#xD;
  &#xD;
        Finally, statistical methods were used to determine whether those parameters was&#xD;
        statistically significant for IDH mutation status、1p/19q codeletion status and tumor grading.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of bule/red ROI</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>The common vessels morphology in the blue region was undamaged vessel lumens which exists in active tumor, while vessels in the red regions presented different stages of vessel necrosis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Histogram of bule/red ROI</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>The bule and red ROI from CCA histogram analysis included1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Glioma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The subjects are not restricted by gender and age. For details, please refer to the&#xD;
          &quot;criteria&quot; column.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with brain space -occupying lesions, have not yet undergone antitumor&#xD;
               therapy;&#xD;
  &#xD;
            -  MRI with T1-contract delayed sequence was performed less than 2 weeks before surgery;&#xD;
  &#xD;
            -  Definite histopathologic diagnosis of glioma.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  WHO 1 gliomas and other non-glioma brain tumors;&#xD;
  &#xD;
            -  Poor image quality and heavy artifact affect the subsequent image processing.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zifan Sang, M.M</last_name>
      <phone>+8618379873389</phone>
      <email>952034224@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sang Zifan</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400042</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zifan Sang, M.M</last_name>
        <phone>+8618379873389</phone>
        <email>952034224@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</investigator_affiliation>
      <investigator_full_name>Weiguo Zhang</investigator_full_name>
      <investigator_title>Chief of radiology department</investigator_title>
    </responsible_party>
    <keyword>Glioma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioma</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/NCT06018870
  org study id: 2023183
  nct id: NCT06018870
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Gliomas are the most common primary brain tumor. Gliomas with different grades have different
        clinical behaviors that determine treatment planning and patient prognosis in clinical
        practice. In the 2021 World Health Organization (WHO) classification of tumors for the
        central nervous system, glioma genotyping was considered the most relevant information for
        neuroradiologists. The isocitrate dehydrogenase (IDH) genotype and 1p/19q codeletion status
        are two essential molecular markers that divide glioma into three groups: IDH wild-type, IDH
        mutant with 1p/19q non-codeletion, and IDH mutant with 1p/19q codeletion.
  
        MRI contrast clearance analysis (CCA) is based on T1 delayed-contrast subtraction map,
        Blue/tumor regions in CCA represent efficient clearance of contrast from the tissue (delayed
        signal<early signal), while red/nontumor regions in CCA represent contrast accumulation
        (delayed signal>early signal).
  
        However, there are not any reports on the role of MRI CCA in glioma grading and genotyping,
        Thus, We hypothesized that the proportion of blue/red region and their histogram analyses,
        which could be acquired for predicting IDH genotypes and 1p/19q codeletion in gliomas, and to
        assess the application of CCA in glioma grading.
  This is a single-center bidirectional cohort study. The subjects of this study were patients
        diagnosed as glioma by pathological biopsy. Patients with suspicious mass will be performed
        extra 30 and 60 min after contrast agent application delayed T1-weighted sequences as same as
        before. Then enter the next experimental stage. (1) Image format conversion; (2)
        Registration;(3) Subtraction;(4) ROI segmentation;(5) ROI histogram analyses. Histogram
        parameters of blue and red ROI includes 1st、10th 、90th and 99th percentiles, mean, median,
        variance, skewness, and kurtosis.
  
        Finally, statistical methods were used to determine whether those parameters was
        statistically significant for IDH mutation status、1p/19q codeletion status and tumor grading.
  observational model: Cohort
  time perspective: Other
  measure: Proportion of bule/red ROI
  time frame: Through study completion, an average of 1 year
  description: The common vessels morphology in the blue region was undamaged vessel lumens which exists in active tumor, while vessels in the red regions presented different stages of vessel necrosis.
  measure: Histogram of bule/red ROI
  time frame: Through study completion, an average of 1 year
  description: The bule and red ROI from CCA histogram analysis included1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Zifan Sang, M.M
  phone: +8618379873389
  email: 952034224@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  investigator full name: Weiguo Zhang
  investigator title: Chief of radiology department
  mesh term: Glioma