<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/NCT04495634</url>
  </required_header>
  <id_info>
    <org_study_id>20-0614</org_study_id>
    <secondary_id>W81XWH1820043</secondary_id>
    <nct_id>NCT04495634</nct_id>
  </id_info>
  <brief_title>Evaluation of a Carbon Nanotube Enabled Solid-State Head CT</brief_title>
  <official_title>Evaluation of a Carbon Nanotube Enabled Solid-State Head CT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: The purpose of this study is to evaluate stationary head CT (s-HCT) as a diagnostic&#xD;
      tool in patients with known head trauma.&#xD;
&#xD;
      Participants: Participants will be 50 people who have had either a head trauma or a brain&#xD;
      bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the&#xD;
      head.&#xD;
&#xD;
      Procedures (methods): This investigation will be a single arm, prospective clinical trial.&#xD;
      Participants will have one single visit, which will include the s-HCT scan. No follow-up is&#xD;
      required. All images will be de-identified before inclusion within a reader study. The&#xD;
      investigators will perform a reader study with physician readers comparing the acquired&#xD;
      imaging s-HCT images and conventional head CT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation will be a single arm, prospective clinical trial evaluating stationary&#xD;
      head CT (s-HCT) as a diagnostic tool in patients with known head trauma. The investigators&#xD;
      hypothesize that a stationary head CT (s-HCT) system based on the carbon nanotube linear&#xD;
      array x-ray source can provide diagnostic quality head CT images. Patients included in the&#xD;
      study will be 50 people who have had either a head trauma or a brain bleed and have undergone&#xD;
      a head CT in the past 24 hours or who will undergo a CT scan of the head.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 12, 2022</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>Sensitivity of Stationary Head CT for the Detection of a Hemorrhage</measure>
    <time_frame>Upon completion of all study image data collection for all participants [approximately 1 year]</time_frame>
    <description>Sensitivity of stationary head CT for the detection of a hemorrhage using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to predict hemorrhage using conventional head CT as the gold standard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity of Stationary Head CT for the Detection of a Hemorrhage</measure>
    <time_frame>Upon completion of all study image data collection for all participants [approximately 1 year]</time_frame>
    <description>Specificity of stationary head CT for the detection of a hemorrhage using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to distinguish between individuals that do not have a hemorrhage using conventional head CT as the gold standard.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of Stationary Head CT for the Detection of a Fracture</measure>
    <time_frame>Upon completion of all study image data collection for all participants [approximately 1 year]</time_frame>
    <description>Sensitivity of stationary head CT for the detection of a fracture using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to predict a fracture using conventional head CT as the gold standard.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of Stationary Head CT for the Detection of a Fracture</measure>
    <time_frame>Upon completion of all study image data collection for all participants [approximately 1 year]</time_frame>
    <description>Specificity of stationary head CT for the detection of a fracture using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to distinguish between individuals that do not have a fracture using conventional head CT as the gold standard.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Head Trauma</condition>
  <arm_group>
    <arm_group_label>Head Trauma or Brain Bleed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stationary Head CT (s-HCT)</intervention_name>
    <description>The system consists of a total of three x-ray sources and nine x-ray detectors with an estimation of approximately 150 projection angles per slice, with less than a minute per slice reconstruction. Radiation dose will be configured as to not exceed that of a conventional head CT, or 2 mSv. The subjects will be positioned on a medical procedure table that will move the subject through the scanning system at the rate of roughly 1 cm per second, during which the necessary x-ray projections will be acquired. The head will be positioned in a carbon fiber head holder from a clinical CT scanner that is secured to the table.</description>
    <arm_group_label>Head Trauma or Brain Bleed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Medically stable patient with head trauma or known intracranial hemorrhage (subdural&#xD;
             or intraparenchymal) or skull fractures&#xD;
&#xD;
          -  Patient has undergone conventional head CT imaging at UNC hospitals within the past 24&#xD;
             hours or will undergo a CT scan of the head&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide consent&#xD;
&#xD;
          -  Any woman who is pregnant or has reason to believe she is pregnant (the possibility of&#xD;
             pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours&#xD;
             prior to the research scan, or on the basis of patient history, e.g., tubal ligation,&#xD;
             hysterectomy or a minimum of 1 year without menses)&#xD;
&#xD;
          -  Breastfeeding&#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>Deanna Sasaki-Adams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Markeela Lipscomb, BS, CCRC</last_name>
    <phone>919-843-3670</phone>
    <email>markeela_lipscomb@med.unc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Doreen Steed, RT(R)(M)</last_name>
    <phone>919-966-0188</phone>
    <email>doreen_steed@med.unc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UNC Hospitals</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markeela Lipscomb, BS, CCRC</last_name>
      <phone>919-843-3670</phone>
      <email>markeela_lipscomb@med.unc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Doreen Steed, RT(R)(M)</last_name>
      <phone>919-966-0188</phone>
      <email>doreen_steed@med.unc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Yueh Lee, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thad Benefield, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Deanna Sasaki-Adams, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</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>Craniocerebral Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
    <ipd_time_frame>9 to 36 months following publication</ipd_time_frame>
    <ipd_access_criteria>The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.</ipd_access_criteria>
  </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/NCT04495634
org study id: 20-0614
secondary id: W81XWH1820043
nct id: NCT04495634
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Purpose: The purpose of this study is to evaluate stationary head CT (s-HCT) as a diagnostic
      tool in patients with known head trauma.

      Participants: Participants will be 50 people who have had either a head trauma or a brain
      bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the
      head.

      Procedures (methods): This investigation will be a single arm, prospective clinical trial.
      Participants will have one single visit, which will include the s-HCT scan. No follow-up is
      required. All images will be de-identified before inclusion within a reader study. The
      investigators will perform a reader study with physician readers comparing the acquired
      imaging s-HCT images and conventional head CT.
This investigation will be a single arm, prospective clinical trial evaluating stationary
      head CT (s-HCT) as a diagnostic tool in patients with known head trauma. The investigators
      hypothesize that a stationary head CT (s-HCT) system based on the carbon nanotube linear
      array x-ray source can provide diagnostic quality head CT images. Patients included in the
      study will be 50 people who have had either a head trauma or a brain bleed and have undergone
      a head CT in the past 24 hours or who will undergo a CT scan of the head.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity of Stationary Head CT for the Detection of a Hemorrhage
time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
description: Sensitivity of stationary head CT for the detection of a hemorrhage using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to predict hemorrhage using conventional head CT as the gold standard.
measure: Specificity of Stationary Head CT for the Detection of a Hemorrhage
time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
description: Specificity of stationary head CT for the detection of a hemorrhage using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to distinguish between individuals that do not have a hemorrhage using conventional head CT as the gold standard.
measure: Sensitivity of Stationary Head CT for the Detection of a Fracture
time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
description: Sensitivity of stationary head CT for the detection of a fracture using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to predict a fracture using conventional head CT as the gold standard.
measure: Specificity of Stationary Head CT for the Detection of a Fracture
time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
description: Specificity of stationary head CT for the detection of a fracture using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to distinguish between individuals that do not have a fracture using conventional head CT as the gold standard.
arm group label: Head Trauma or Brain Bleed
arm group type: Experimental
description: Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system.
intervention type: Device
intervention name: Stationary Head CT (s-HCT)
description: The system consists of a total of three x-ray sources and nine x-ray detectors with an estimation of approximately 150 projection angles per slice, with less than a minute per slice reconstruction. Radiation dose will be configured as to not exceed that of a conventional head CT, or 2 mSv. The subjects will be positioned on a medical procedure table that will move the subject through the scanning system at the rate of roughly 1 cm per second, during which the necessary x-ray projections will be acquired. The head will be positioned in a carbon fiber head holder from a clinical CT scanner that is secured to the table.
arm group label: Head Trauma or Brain Bleed
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Deanna Sasaki-Adams, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Markeela Lipscomb, BS, CCRC
phone: 919-843-3670
email: markeela_lipscomb@med.unc.edu
last name: Doreen Steed, RT(R)(M)
phone: 919-966-0188
email: doreen_steed@med.unc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Craniocerebral Trauma
sharing ipd: Yes
ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
ipd time frame: 9 to 36 months following publication
ipd access criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.