<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/NCT04490954</url>
  </required_header>
  <id_info>
    <org_study_id>IR2019001127</org_study_id>
    <nct_id>NCT04490954</nct_id>
  </id_info>
  <brief_title>The Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors</brief_title>
  <acronym>ABST</acronym>
  <official_title>A Prospective, Self-paired, Single-center Clinical Trial Evaluating the Accuracy of Brain Biological Electrical Impedance Tomography Screen for Supratentorial Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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>
      Compared with MRI or CT, brain biological electrical impedance tomography were performed on&#xD;
      patients with supratentorial tumors and healthy people . The AUC (area under the curve) of&#xD;
      ROC, which is associated with the increased maximum and the difference between left and right&#xD;
      equilibrium of impedance value, is calculated. The specificity of brain biological electrical&#xD;
      impedance tomography in screening supratentorial tumors are evaluated.&#xD;
&#xD;
      To compare the changes of parameters detected by brain biological electrical impedance&#xD;
      tomography, the enrolled brain tumor patients with cerebral edema were paired with themselves&#xD;
      and intravenous infusion of mannitol so that the sensitivity of this device in monitoring&#xD;
      cerebral edema can be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compared with MRI or CT, brain biological electrical impedance tomography were performed on&#xD;
      patients with supratentorial tumors and healthy people . The AUC (area under the curve) of&#xD;
      ROC, which is associated with the increased maximum and the difference between left and right&#xD;
      equilibrium of impedance value, is calculated. The specificity of brain biological electrical&#xD;
      impedance tomography in screening supratentorial tumors are evaluated.&#xD;
&#xD;
      To compare the changes of parameters detected by brain biological electrical impedance&#xD;
      tomography, the enrolled brain tumor patients with cerebral edema were paired with themselves&#xD;
      and intravenous infusion of mannitol so that the sensitivity of this device in monitoring&#xD;
      cerebral edema can be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The AUC of ROC curve of the maximum increased value of impedance</measure>
    <time_frame>1 year</time_frame>
    <description>The AUC of ROC curve of the maximum increased value of impedance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the difference between the left and right equilibrium</measure>
    <time_frame>1 year</time_frame>
    <description>the difference between the left and right equilibrium</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Brain Tumor</condition>
  <condition>Brain Edema</condition>
  <arm_group>
    <arm_group_label>Patients examined with MRI/CT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients examined with biological electrical impedance</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>brain biological electrical impedance tomography</intervention_name>
    <description>Patients diagnosed with brain supratentorial tumors through MRI/CT are evaluated with brain biological electrical impedance tomography. And the brain biological electrical impedance tomography is used to monitor the cerebral edema situation of patients with brain edema</description>
    <arm_group_label>Patients examined with biological electrical impedance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI/CT</intervention_name>
    <description>Patients diagnosed with brain supratentorial tumors through MRI/CT</description>
    <arm_group_label>Patients examined with MRI/CT</arm_group_label>
    <arm_group_label>Patients examined with biological electrical impedance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 ≤70 years old, male or female;&#xD;
&#xD;
          2. Preoperative patients who had been diagnosed with supratentorial tumors by MRI/CT or&#xD;
             other conventional methods or healthy people (23 cases each);&#xD;
&#xD;
          3. The longest diameter of the brain tumor is ≥3 cm;&#xD;
&#xD;
          4. Informed Consent Has been signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe systemic compound injury or hemorrhagic shock;&#xD;
&#xD;
          2. Epilepsy, poisoning symptoms;&#xD;
&#xD;
          3. In critical condition;&#xD;
&#xD;
          4. Patients with brain wounds or acute inflammation;&#xD;
&#xD;
          5. Lactation and pregnant women;&#xD;
&#xD;
          6. Those who have no informed consent ability or cannot sign by themselves;&#xD;
&#xD;
          7. The investigator considers it inappropriate for the patient to participate in this&#xD;
             clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>1 year 1 year, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of neurosurgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jianmin Zhang</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electrical Impedance Tomography</keyword>
  <keyword>Supratentorial Brain Tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Supratentorial Neoplasms</mesh_term>
    <mesh_term>Brain Edema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04490954
org study id: IR2019001127
nct id: NCT04490954
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Compared with MRI or CT, brain biological electrical impedance tomography were performed on
      patients with supratentorial tumors and healthy people . The AUC (area under the curve) of
      ROC, which is associated with the increased maximum and the difference between left and right
      equilibrium of impedance value, is calculated. The specificity of brain biological electrical
      impedance tomography in screening supratentorial tumors are evaluated.

      To compare the changes of parameters detected by brain biological electrical impedance
      tomography, the enrolled brain tumor patients with cerebral edema were paired with themselves
      and intravenous infusion of mannitol so that the sensitivity of this device in monitoring
      cerebral edema can be evaluated.
Compared with MRI or CT, brain biological electrical impedance tomography were performed on
      patients with supratentorial tumors and healthy people . The AUC (area under the curve) of
      ROC, which is associated with the increased maximum and the difference between left and right
      equilibrium of impedance value, is calculated. The specificity of brain biological electrical
      impedance tomography in screening supratentorial tumors are evaluated.

      To compare the changes of parameters detected by brain biological electrical impedance
      tomography, the enrolled brain tumor patients with cerebral edema were paired with themselves
      and intravenous infusion of mannitol so that the sensitivity of this device in monitoring
      cerebral edema can be evaluated.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The AUC of ROC curve of the maximum increased value of impedance
time frame: 1 year
description: The AUC of ROC curve of the maximum increased value of impedance
measure: the difference between the left and right equilibrium
time frame: 1 year
description: the difference between the left and right equilibrium
arm group label: Patients examined with MRI/CT
arm group type: Other
arm group label: Patients examined with biological electrical impedance
arm group type: Other
intervention type: Device
intervention name: brain biological electrical impedance tomography
description: Patients diagnosed with brain supratentorial tumors through MRI/CT are evaluated with brain biological electrical impedance tomography. And the brain biological electrical impedance tomography is used to monitor the cerebral edema situation of patients with brain edema
arm group label: Patients examined with biological electrical impedance
intervention type: Device
intervention name: MRI/CT
description: Patients diagnosed with brain supratentorial tumors through MRI/CT
arm group label: Patients examined with MRI/CT
arm group label: Patients examined with biological electrical impedance
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: 1 year 1 year, M.D.
role: Principal Investigator
affiliation: Department of neurosurgery
facility: 
country: China
responsible party type: Sponsor
mesh term: Brain Neoplasms
mesh term: Supratentorial Neoplasms
mesh term: Brain Edema
sharing ipd: No