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/NCT05990244</url>
    </required_header>
    <id_info>
      <org_study_id>ShengjingH_glioma2023</org_study_id>
      <nct_id>NCT05990244</nct_id>
    </id_info>
    <brief_title>Magnetic Resonance Elastography in Glioma: Exploring Tumor Stiffness and Adhesion</brief_title>
    <official_title>Comprehensive Assessment of Tumor Stiffness and Adhesion in Glioma Using Magnetic Resonance Elastography: A Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shengjing Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shengjing Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 study will investigate the relationship between tumor stiffness and adhesion in gliomas&#xD;
        using MRE. By utilizing preoperative MRE and Intraoperative neuronavigation, followed by&#xD;
        comprehensive molecular pathology analysis, we aim to explore the correlation of tumor&#xD;
        stiffness and adhesion with molecular and genetic characteristics of gliomas. Additionally,&#xD;
        the predictive value of MRE in terms of pathological staging and prognosis will be&#xD;
        determined. This research may pave the way for improved clinical decision-making,&#xD;
        personalized treatment approaches, and more accurate clinical trials for glioma patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Magnetic Resonance Elastography (MRE) is an advanced imaging technique that measures the&#xD;
        mechanical properties of tissues, providing valuable information about tissue stiffness,&#xD;
        elasticity, and adhesion. In the case of gliomas, a type of brain tumor arising from glial&#xD;
        cells, MRE has shown promising potential in the diagnosis, classification, and prediction of&#xD;
        pathological and molecular features.&#xD;
  &#xD;
        This clinical trial aims to investigate the relationship between tumor stiffness, adhesion,&#xD;
        glioma grading, and genetic alterations by combining magnetic resonance elastography (MRE)&#xD;
        imaging findings with molecular pathological analysis. Moreover, the study aims to predict&#xD;
        patient survival based on the physical properties of the tumor.&#xD;
  &#xD;
        Preoperatively, we will use MRE to enhance the accuracy of navigation and determine tumor&#xD;
        stiffness and adhesion properties. Intraoperatively, under the guidance of neuronavigation,&#xD;
        tissue samples will be obtained, and the operating surgeon will assess the tumor's stiffness,&#xD;
        elasticity, and degree of adhesion.&#xD;
  &#xD;
        Postoperatively, all tissue specimens will undergo molecular pathological analysis. The&#xD;
        integration of MRE findings with molecular pathology data will enable precise classification&#xD;
        and subtyping of gliomas.&#xD;
  &#xD;
        Furthermore, all patients will receive systematic treatment after surgery, and long-term&#xD;
        follow-ups will be conducted. This comprehensive approach combining MRE, molecular pathology&#xD;
        analysis, and clinical follow-up aims to investigate the predictive value of MRE in terms of&#xD;
        molecular pathological features and prognosis in gliomas.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>Surgical assessment of tumor stiffness</measure>
      <time_frame>Baseline to 6 weeks</time_frame>
      <description>The surgeon will score the tumor stiffness in seven aspects, ranging from 1 to 5 points: Tumor size; Shape of tumor; Tumor texture; Stiffness of the tumor's capsule; Stiffness of the tumor's central region; Primary methods of tumor removal; Features of tumor's capsule.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Surgical assessment of tumor adhesion</measure>
      <time_frame>Baseline to 6 weeks</time_frame>
      <description>The surgeon will score the tumor's adhesion based on seven aspects, ranging from 1 to 4 points: Stripping instruments; Frequency of use of sharp instruments; Adhesion range; Degree of tumor resection; Cranial nerve anatomy preservation; Brain tissue anatomy preservation; Neurological function (compared with preoperative).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Radiological assessment of tumor stiffness</measure>
      <time_frame>Baseline to 6 weeks</time_frame>
      <description>Tumor stiffness, measured in kilopascals (kPa), will be compared with its normal-appearing contralateral white matter using MRE by creating a lesion region of interest (ROI). Images were acquired on a 3T MR imaging unit with a vibration frequency of 60 Hz. The performance of the use of tumor stiffness to predict tumor grade was evaluated with the Wilcoxon rank sum, 1-way ANOVA, and Tukey-Kramer tests.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Glioma</condition>
    <arm_group>
      <arm_group_label>Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery to assess tumor stiffness and adhesion. Additionally, molecular pathological analysis will be performed to identify genetic alterations in gliomas. During surgery, the tumor stiffness and adhesion will be assessed and recorded by the surgeon according to established evaluation criteria.&#xD;
  It is important to note that the surgeon does not have prior knowledge of the tumor's specific stiffness before the surgery. This information is typically obtained through intraoperative assessment and observation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Magnetic Resonance Elastography</intervention_name>
      <description>Undergo MRE and routine MRI</description>
      <arm_group_label>Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)</arm_group_label>
      <other_name>MRE</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Assessment and Recording</intervention_name>
      <description>Undergo recording of tumor stiffness during surgery and molecular pathological classification through genetic analysis</description>
      <arm_group_label>Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients undergoing glioma resection surgery are eligible for inclusion in the&#xD;
               study cohort.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with metallic implants or foreign bodies in their bodies (pacemakers,&#xD;
               artificial metallic heart valves, metal joints, metal implants, and those who cannot&#xD;
               remove dentures, insulin pumps, or contraceptive rings)&#xD;
  &#xD;
            -  Pregnant women in the first trimester (within three months)&#xD;
  &#xD;
            -  Patients with severe claustrophobia or anxiety&#xD;
  &#xD;
            -  Patients with severe fever&#xD;
  &#xD;
            -  Patients who can not tolerate MRE&#xD;
  &#xD;
            -  Patients with vascular malformations and aneurysms.&#xD;
  &#xD;
            -  Patients who do not sign an informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yu Shi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shengjing Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Anhua Wu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shengjing Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Wen Cheng, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shengjing Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yu Shi, MD</last_name>
      <phone>+86 189 4025 9980</phone>
      <email>18940259980@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wen Cheng, MD</last_name>
      <phone>+86 150 4023 5535</phone>
      <email>cmu071207@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shengjing Hospital</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yu Shi, MD</last_name>
        <phone>+8618940259980</phone>
        <email>18940259980@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Anhua Wu, MD</last_name>
        <phone>+8618900925766</phone>
        <email>wuanhua@yahoo.com</email>
      </contact_backup>
      <investigator>
        <last_name>Yu Shi, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Anhua Wu, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Wen Cheng, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Murphy MC, Huston J 3rd, Glaser KJ, Manduca A, Meyer FB, Lanzino G, Morris JM, Felmlee JP, Ehman RL. Preoperative assessment of meningioma stiffness using magnetic resonance elastography. J Neurosurg. 2013 Mar;118(3):643-8. doi: 10.3171/2012.9.JNS12519. Epub 2012 Oct 19.</citation>
      <PMID>23082888</PMID>
    </reference>
    <reference>
      <citation>Hughes JD, Fattahi N, Van Gompel J, Arani A, Meyer F, Lanzino G, Link MJ, Ehman R, Huston J. Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. Neurosurgery. 2015 Oct;77(4):653-8; discussion 658-9. doi: 10.1227/NEU.0000000000000892.</citation>
      <PMID>26197204</PMID>
    </reference>
    <reference>
      <citation>Yin Z, Lu X, Cohen Cohen S, Sui Y, Manduca A, Van Gompel JJ, Ehman RL, Huston J 3rd. A new method for quantification and 3D visualization of brain tumor adhesion using slip interface imaging in patients with meningiomas. Eur Radiol. 2021 Aug;31(8):5554-5564. doi: 10.1007/s00330-021-07918-6. Epub 2021 Apr 14.</citation>
      <PMID>33852045</PMID>
    </reference>
    <reference>
      <citation>Yin Z, Hughes JD, Trzasko JD, Glaser KJ, Manduca A, Van Gompel J, Link MJ, Romano A, Ehman RL, Huston J 3rd. Slip interface imaging based on MR-elastography preoperatively predicts meningioma-brain adhesion. J Magn Reson Imaging. 2017 Oct;46(4):1007-1016. doi: 10.1002/jmri.25623. Epub 2017 Feb 14. Erratum In: J Magn Reson Imaging. 2017 Dec;46(6):1851.</citation>
      <PMID>28194925</PMID>
    </reference>
    <reference>
      <citation>Pepin KM, McGee KP, Arani A, Lake DS, Glaser KJ, Manduca A, Parney IF, Ehman RL, Huston J 3rd. MR Elastography Analysis of Glioma Stiffness and IDH1-Mutation Status. AJNR Am J Neuroradiol. 2018 Jan;39(1):31-36. doi: 10.3174/ajnr.A5415. Epub 2017 Oct 26.</citation>
      <PMID>29074637</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shengjing Hospital</investigator_affiliation>
      <investigator_full_name>Yu Shi</investigator_full_name>
      <investigator_title>Deputy director of department of radology</investigator_title>
    </responsible_party>
    <keyword>Magnetic Resonance Elastography</keyword>
    <keyword>Brain tumor</keyword>
    <keyword>Glioblastoma</keyword>
    <keyword>MR elastography</keyword>
    <keyword>Tumor molecular pathology</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioma</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/NCT05990244
  org study id: ShengjingH_glioma2023
  nct id: NCT05990244
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  this study will investigate the relationship between tumor stiffness and adhesion in gliomas
        using MRE. By utilizing preoperative MRE and Intraoperative neuronavigation, followed by
        comprehensive molecular pathology analysis, we aim to explore the correlation of tumor
        stiffness and adhesion with molecular and genetic characteristics of gliomas. Additionally,
        the predictive value of MRE in terms of pathological staging and prognosis will be
        determined. This research may pave the way for improved clinical decision-making,
        personalized treatment approaches, and more accurate clinical trials for glioma patients.
  Magnetic Resonance Elastography (MRE) is an advanced imaging technique that measures the
        mechanical properties of tissues, providing valuable information about tissue stiffness,
        elasticity, and adhesion. In the case of gliomas, a type of brain tumor arising from glial
        cells, MRE has shown promising potential in the diagnosis, classification, and prediction of
        pathological and molecular features.
  
        This clinical trial aims to investigate the relationship between tumor stiffness, adhesion,
        glioma grading, and genetic alterations by combining magnetic resonance elastography (MRE)
        imaging findings with molecular pathological analysis. Moreover, the study aims to predict
        patient survival based on the physical properties of the tumor.
  
        Preoperatively, we will use MRE to enhance the accuracy of navigation and determine tumor
        stiffness and adhesion properties. Intraoperatively, under the guidance of neuronavigation,
        tissue samples will be obtained, and the operating surgeon will assess the tumor's stiffness,
        elasticity, and degree of adhesion.
  
        Postoperatively, all tissue specimens will undergo molecular pathological analysis. The
        integration of MRE findings with molecular pathology data will enable precise classification
        and subtyping of gliomas.
  
        Furthermore, all patients will receive systematic treatment after surgery, and long-term
        follow-ups will be conducted. This comprehensive approach combining MRE, molecular pathology
        analysis, and clinical follow-up aims to investigate the predictive value of MRE in terms of
        molecular pathological features and prognosis in gliomas.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Surgical assessment of tumor stiffness
  time frame: Baseline to 6 weeks
  description: The surgeon will score the tumor stiffness in seven aspects, ranging from 1 to 5 points: Tumor size; Shape of tumor; Tumor texture; Stiffness of the tumor's capsule; Stiffness of the tumor's central region; Primary methods of tumor removal; Features of tumor's capsule.
  measure: Surgical assessment of tumor adhesion
  time frame: Baseline to 6 weeks
  description: The surgeon will score the tumor's adhesion based on seven aspects, ranging from 1 to 4 points: Stripping instruments; Frequency of use of sharp instruments; Adhesion range; Degree of tumor resection; Cranial nerve anatomy preservation; Brain tissue anatomy preservation; Neurological function (compared with preoperative).
  measure: Radiological assessment of tumor stiffness
  time frame: Baseline to 6 weeks
  description: Tumor stiffness, measured in kilopascals (kPa), will be compared with its normal-appearing contralateral white matter using MRE by creating a lesion region of interest (ROI). Images were acquired on a 3T MR imaging unit with a vibration frequency of 60 Hz. The performance of the use of tumor stiffness to predict tumor grade was evaluated with the Wilcoxon rank sum, 1-way ANOVA, and Tukey-Kramer tests.
  arm group label: Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)
  arm group type: Experimental
  description: Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery to assess tumor stiffness and adhesion. Additionally, molecular pathological analysis will be performed to identify genetic alterations in gliomas. During surgery, the tumor stiffness and adhesion will be assessed and recorded by the surgeon according to established evaluation criteria.
  It is important to note that the surgeon does not have prior knowledge of the tumor's specific stiffness before the surgery. This information is typically obtained through intraoperative assessment and observation.
  intervention type: Diagnostic Test
  intervention name: Magnetic Resonance Elastography
  description: Undergo MRE and routine MRI
  arm group label: Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)
  other name: MRE
  intervention type: Procedure
  intervention name: Assessment and Recording
  description: Undergo recording of tumor stiffness during surgery and molecular pathological classification through genetic analysis
  arm group label: Diagnostic (MRE, tumor grade, tumor stiffness and adhesion)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yu Shi, MD
  role: Principal Investigator
  affiliation: Shengjing Hospital
  last name: Anhua Wu, MD
  role: Principal Investigator
  affiliation: Shengjing Hospital
  last name: Wen Cheng, MD
  role: Principal Investigator
  affiliation: Shengjing Hospital
  last name: Yu Shi, MD
  phone: +86 189 4025 9980
  email: 18940259980@163.com
  last name: Wen Cheng, MD
  phone: +86 150 4023 5535
  email: cmu071207@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  citation: Murphy MC, Huston J 3rd, Glaser KJ, Manduca A, Meyer FB, Lanzino G, Morris JM, Felmlee JP, Ehman RL. Preoperative assessment of meningioma stiffness using magnetic resonance elastography. J Neurosurg. 2013 Mar;118(3):643-8. doi: 10.3171/2012.9.JNS12519. Epub 2012 Oct 19.
  PMID: 23082888
  citation: Hughes JD, Fattahi N, Van Gompel J, Arani A, Meyer F, Lanzino G, Link MJ, Ehman R, Huston J. Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. Neurosurgery. 2015 Oct;77(4):653-8; discussion 658-9. doi: 10.1227/NEU.0000000000000892.
  PMID: 26197204
  citation: Yin Z, Lu X, Cohen Cohen S, Sui Y, Manduca A, Van Gompel JJ, Ehman RL, Huston J 3rd. A new method for quantification and 3D visualization of brain tumor adhesion using slip interface imaging in patients with meningiomas. Eur Radiol. 2021 Aug;31(8):5554-5564. doi: 10.1007/s00330-021-07918-6. Epub 2021 Apr 14.
  PMID: 33852045
  citation: Yin Z, Hughes JD, Trzasko JD, Glaser KJ, Manduca A, Van Gompel J, Link MJ, Romano A, Ehman RL, Huston J 3rd. Slip interface imaging based on MR-elastography preoperatively predicts meningioma-brain adhesion. J Magn Reson Imaging. 2017 Oct;46(4):1007-1016. doi: 10.1002/jmri.25623. Epub 2017 Feb 14. Erratum In: J Magn Reson Imaging. 2017 Dec;46(6):1851.
  PMID: 28194925
  citation: Pepin KM, McGee KP, Arani A, Lake DS, Glaser KJ, Manduca A, Parney IF, Ehman RL, Huston J 3rd. MR Elastography Analysis of Glioma Stiffness and IDH1-Mutation Status. AJNR Am J Neuroradiol. 2018 Jan;39(1):31-36. doi: 10.3174/ajnr.A5415. Epub 2017 Oct 26.
  PMID: 29074637
  responsible party type: Principal Investigator
  investigator affiliation: Shengjing Hospital
  investigator full name: Yu Shi
  investigator title: Deputy director of department of radology
  mesh term: Glioma
  sharing ipd: No