<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/NCT03293888</url>
  </required_header>
  <id_info>
    <org_study_id>8285</org_study_id>
    <nct_id>NCT03293888</nct_id>
  </id_info>
  <brief_title>Spectral Analysis Probe to Identify Glioblastoma Cells</brief_title>
  <official_title>Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</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 is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos&#xD;
      Wand in detecting tumor tissue with glioblastoma disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study to investigate if the Chaos Wand Spectral Diagnosis Probe can be used&#xD;
      to identify Glioblastoma (GBM) cancer cells in patients undergoing standard surgical&#xD;
      resection. Eligible patients who have consented to the use of the Chaos Wand will be&#xD;
      scheduled for surgery as standard cancer care for GBM. During the surgical procedure, the&#xD;
      Chaos Wand Spectral Diagnosis Probe will be utilized. Fifteen intraoperative readings and&#xD;
      signal recordings of GBM tissue will be taken. The wand will only be used in areas that have&#xD;
      already been deemed in need of resection due to GBM disease. Each site identified for&#xD;
      spectral analysis will be marked. The wand does not come into contact with the brain at any&#xD;
      point during this procedure. Following surgical resection of the GBM tumor, tissue will be&#xD;
      collected from the same 15 sites where the Chaos Wand was used. The pathology report will be&#xD;
      compared with the results of spectral analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI Relocation&#xD;
  </why_stopped>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth</measure>
    <time_frame>6 months</time_frame>
    <description>For participants newly diagnosed with glioblastoma multiforme or patients who are suspected of having glioblastoma on pre-operative imaging who consent to the use of the Chaos Wand during surgery, 15-20 spectral readings will be compared to histopathology as ground truth to measure the sensitivity of the Chaos Wand to detect glioblastoma. For example, if a patient has 15 spectral readings but only 13 are histologically consistent with cancer, then the sensitivity of the wand would be 13/15*100 = 87%. A mean value with standard deviation will be reported across all participants in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery</measure>
    <time_frame>Up to 1 month following surgery</time_frame>
    <description>For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of intracranial hemorrhage during the post-operative hospital course will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing post-operative ischemic stroke following surgical resection of glioblastoma with use of the Chaos Wand during surgery</measure>
    <time_frame>Up to 1 month following surgery</time_frame>
    <description>For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of ischemic stroke during the post-operative hospital course will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing post-operative surgical site infection following surgical resection of glioblastoma with use of the Chaos Wand during surgery</measure>
    <time_frame>Up to 1 month following surgery</time_frame>
    <description>For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of surgical site infection during the post-operative hospital course will be measured.</description>
  </secondary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Glioblastoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissue from surgically resected tumor&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes adult patients from the outpatient neurosurgery clinic or&#xD;
        those who have presented through the University of Oklahoma emergency department and have&#xD;
        been diagnosed with glioblastoma or are suspected of having glioblastoma based on&#xD;
        pre-operative imaging. The Stephenson Cancer Center will not exclude potential subjects&#xD;
        from participating in this or any study solely on the basis of ethnic origin or&#xD;
        socioeconomic status. Every attempt will be made to enter all eligible patients into this&#xD;
        protocol and therefore address the study objectives in a patient population representative&#xD;
        of the entire patient population with GBM.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or Female and over 18 years of age.&#xD;
&#xD;
          2. Patients with histologically proven GBM who are newly diagnosed and eligible to&#xD;
             undergo surgical treatment or patients who are suspected of having glioblastoma on&#xD;
             pre-operative imaging which is subsequently confirmed by histopathology following&#xD;
             tumor resection.&#xD;
&#xD;
          3. Patients must be able to understand and willing to sign the informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with absence of glioblastoma.&#xD;
&#xD;
          2. Patients who are not undergoing tumor resection.&#xD;
&#xD;
          3. Patients who have prior brain radiotherapy&#xD;
&#xD;
          4. Patients who have prior systemic chemotherapy&#xD;
&#xD;
          5. Patients who are not willing to sign the informed consent and agree to participate.&#xD;
&#xD;
          6. Patients who are pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Sughrue, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spectral Diagnosis Probe</keyword>
  <keyword>Chaos Wand</keyword>
  <keyword>Spectral Analysis</keyword>
  <keyword>Optical Spectroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT03293888
org study id: 8285
nct id: NCT03293888
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos
      Wand in detecting tumor tissue with glioblastoma disease.
This is a pilot study to investigate if the Chaos Wand Spectral Diagnosis Probe can be used
      to identify Glioblastoma (GBM) cancer cells in patients undergoing standard surgical
      resection. Eligible patients who have consented to the use of the Chaos Wand will be
      scheduled for surgery as standard cancer care for GBM. During the surgical procedure, the
      Chaos Wand Spectral Diagnosis Probe will be utilized. Fifteen intraoperative readings and
      signal recordings of GBM tissue will be taken. The wand will only be used in areas that have
      already been deemed in need of resection due to GBM disease. Each site identified for
      spectral analysis will be marked. The wand does not come into contact with the brain at any
      point during this procedure. Following surgical resection of the GBM tumor, tissue will be
      collected from the same 15 sites where the Chaos Wand was used. The pathology report will be
      compared with the results of spectral analysis.
observational model: Case-Only
time perspective: Prospective
measure: Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth
time frame: 6 months
description: For participants newly diagnosed with glioblastoma multiforme or patients who are suspected of having glioblastoma on pre-operative imaging who consent to the use of the Chaos Wand during surgery, 15-20 spectral readings will be compared to histopathology as ground truth to measure the sensitivity of the Chaos Wand to detect glioblastoma. For example, if a patient has 15 spectral readings but only 13 are histologically consistent with cancer, then the sensitivity of the wand would be 13/15*100 = 87%. A mean value with standard deviation will be reported across all participants in the study.
measure: Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery
time frame: Up to 1 month following surgery
description: For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of intracranial hemorrhage during the post-operative hospital course will be measured.
measure: Number of participants experiencing post-operative ischemic stroke following surgical resection of glioblastoma with use of the Chaos Wand during surgery
time frame: Up to 1 month following surgery
description: For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of ischemic stroke during the post-operative hospital course will be measured.
measure: Number of participants experiencing post-operative surgical site infection following surgical resection of glioblastoma with use of the Chaos Wand during surgery
time frame: Up to 1 month following surgery
description: For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of surgical site infection during the post-operative hospital course will be measured.
Tissue from surgically resected tumor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Sughrue, MD
role: Principal Investigator
affiliation: University of Oklahoma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma