<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/NCT03291964</url>
  </required_header>
  <id_info>
    <org_study_id>17254</org_study_id>
    <nct_id>NCT03291964</nct_id>
  </id_info>
  <brief_title>Rapid MRI for Acute Pediatric Head Trauma</brief_title>
  <official_title>QuickBrain MRI for Acute Pediatric Head Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</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>
      Pediatric head trauma is a leading cause of morbidity and mortality for children/adolescents.&#xD;
      The current standard of care regarding imaging modality when concerned for an acute head&#xD;
      injury is CT. This exposes children to radiation that may predispose to future malignancy.&#xD;
      Rapid MRI is a test that eliminates radiation and has expanded uses in multiple other areas.&#xD;
      This study is evaluating it for pediatric acute head trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Initial retrospective study suggests that QbMRI has adequate sensitivity to detect acute&#xD;
      ciTBIs in children. This preliminary study included all pediatric trauma patients presenting&#xD;
      to OHSU from 2/2010 through 12/2013 who had both a head CT and QbMRI. The current standard of&#xD;
      care in the pediatric ICU at OHSU is for patients admitted with an acute head injury to&#xD;
      undergo routine QbMRI follow up to assess status of the injury rather than a repeat head CT.&#xD;
      Our study team collected clinical data on these patients that included clinical interventions&#xD;
      and then de-identified all head CT and QbMRI images for this cohort. The images were then&#xD;
      independently reviewed by 2 neuroradiology fellows at OHSU (Please refer to Figure 1). The&#xD;
      sensitivity of QbMRI to detect any radiographic injury was 85% (95% CI: 73, 93), but&#xD;
      increased when evaluating clinically important TBIs to 100% (95% CI: 89, 100). The largest&#xD;
      limitation of this study was the variable and often long time interval between acquisition of&#xD;
      the head CT and QbMRI. The average length of time between the initial head CT and QbMRI was&#xD;
      27.5 hours with only 41% receiving both imaging tests within 12 hours of each other. Also,&#xD;
      preliminary data was collected by retrospective review. As such, it is very promising that&#xD;
      initial study had high sensitivity, but further prospective pilot data with a shorter&#xD;
      interval between the index and reference test is needed to assess the discrepancy between the&#xD;
      two types of lesions (radiographic vs clinically important) and feasibility of obtaining&#xD;
      qbMRI in the setting of acute pediatric head trauma. While this study did not miss any&#xD;
      clinically important TBIs, on further review of radiographic &quot;missed lesions&quot;, the study&#xD;
      pediatric neurosurgeon noted signs of a healing bleed. This may suggest that they were&#xD;
      &quot;missed&quot; because they were healed rather than present and not seen. All patients that did not&#xD;
      have a lesion identified on QbMRI did not require significant clinical interventions and only&#xD;
      underwent periods of observation in the hospital. However, this raises the need for a&#xD;
      prospective trial to obtain QbMRI imaging within the same time frame sequentially after the&#xD;
      initial head CT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)</measure>
    <time_frame>within 6 hours from the initial head CT</time_frame>
    <description>Sensitivity of Rapid MRI for detection of a clinically important intracranial injury: Percentage of MRIs identifying clinically important intracranial injury. Sensitivity was calculated as the number of true positives divided by &quot;true positive plus false negative&quot;. True positive was defined based on meeting clinical criteria for a clinically important TBI and if the imaging found the injury.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time From Order to Obtaining MRI</measure>
    <time_frame>During initial ER stay within 3 hours from time of entry to the ER</time_frame>
    <description>minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication)</measure>
    <time_frame>During initial ER stay within 3 hours from time of entry to the ER</time_frame>
    <description>Number of patients requiring medication to obtain imaging</description>
  </secondary_outcome>
  <enrollment type="Actual">76</enrollment>
  <condition>Head Trauma</condition>
  <condition>Image, Body</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rapid Brain MRI</intervention_name>
    <description>Children undergoing head CT for evaluation of acute head injury will also undergo rapid brain MRI with GRE sequence that is specific for blood. Their clinical care will not change at all based on the MRI.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All pediatric trauma patients being evaluated with a head CT for acute intracranial injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient presents to the pediatric emergency department or trauma system at OHSU or&#xD;
             is a trauma system transfer patient to OHSU&#xD;
&#xD;
          2. Age 0-14 years.&#xD;
&#xD;
          3. Being evaluated for a traumatic head injury and attending physician decides to obtain&#xD;
             a head CT.&#xD;
&#xD;
          4. Clinically stable for additional testing: provider deems it safe to obtain a QbMRI in&#xD;
             the ED without deep sedation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is from outside hospital and head CT was performed greater than 6 hours prior&#xD;
&#xD;
          2. Subject is from outside hospital and initial head CT is not in our imaging system for&#xD;
             review&#xD;
&#xD;
          3. History of intracranial surgery&#xD;
&#xD;
          4. History of metallic implants making MRI contraindicated&#xD;
&#xD;
          5. Decompressive surgery prior to QbMRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>David Sheridan, MD MCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>August 24, 2020</results_first_submitted>
  <results_first_submitted_qc>April 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2023</results_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Dr. David Sheridan</investigator_full_name>
    <investigator_title>Assistant Professor of Emergency Medicine/Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03291964/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03291964/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Quick Brain</title>
          <description>Pediatric head trauma patients</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>children being evaluated in the ED for head trauma.</population>
      <group_list>
        <group group_id="B1">
          <title>Quick Brain</title>
          <description>Pediatric head trauma patients</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="73"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.0" lower_limit="1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)</title>
        <description>Sensitivity of Rapid MRI for detection of a clinically important intracranial injury: Percentage of MRIs identifying clinically important intracranial injury. Sensitivity was calculated as the number of true positives divided by &quot;true positive plus false negative&quot;. True positive was defined based on meeting clinical criteria for a clinically important TBI and if the imaging found the injury.</description>
        <time_frame>within 6 hours from the initial head CT</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Quick Brain</title>
            <description>Pediatric head trauma patients</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)</title>
          <description>Sensitivity of Rapid MRI for detection of a clinically important intracranial injury: Percentage of MRIs identifying clinically important intracranial injury. Sensitivity was calculated as the number of true positives divided by &quot;true positive plus false negative&quot;. True positive was defined based on meeting clinical criteria for a clinically important TBI and if the imaging found the injury.</description>
          <units>Percentage of MRIs correctly identifying</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Order to Obtaining MRI</title>
        <description>minutes</description>
        <time_frame>During initial ER stay within 3 hours from time of entry to the ER</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication)</title>
        <description>Number of patients requiring medication to obtain imaging</description>
        <time_frame>During initial ER stay within 3 hours from time of entry to the ER</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Quick Brain</title>
          <description>Pediatric head trauma patients</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Sheridan Assistant Prof</name_or_title>
      <organization>Oregon Health and Science university</organization>
      <phone>5034941691</phone>
      <email>sheridda@ohsu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03291964
org study id: 17254
nct id: NCT03291964
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pediatric head trauma is a leading cause of morbidity and mortality for children/adolescents.
      The current standard of care regarding imaging modality when concerned for an acute head
      injury is CT. This exposes children to radiation that may predispose to future malignancy.
      Rapid MRI is a test that eliminates radiation and has expanded uses in multiple other areas.
      This study is evaluating it for pediatric acute head trauma.
Initial retrospective study suggests that QbMRI has adequate sensitivity to detect acute
      ciTBIs in children. This preliminary study included all pediatric trauma patients presenting
      to OHSU from 2/2010 through 12/2013 who had both a head CT and QbMRI. The current standard of
      care in the pediatric ICU at OHSU is for patients admitted with an acute head injury to
      undergo routine QbMRI follow up to assess status of the injury rather than a repeat head CT.
      Our study team collected clinical data on these patients that included clinical interventions
      and then de-identified all head CT and QbMRI images for this cohort. The images were then
      independently reviewed by 2 neuroradiology fellows at OHSU (Please refer to Figure 1). The
      sensitivity of QbMRI to detect any radiographic injury was 85% (95% CI: 73, 93), but
      increased when evaluating clinically important TBIs to 100% (95% CI: 89, 100). The largest
      limitation of this study was the variable and often long time interval between acquisition of
      the head CT and QbMRI. The average length of time between the initial head CT and QbMRI was
      27.5 hours with only 41% receiving both imaging tests within 12 hours of each other. Also,
      preliminary data was collected by retrospective review. As such, it is very promising that
      initial study had high sensitivity, but further prospective pilot data with a shorter
      interval between the index and reference test is needed to assess the discrepancy between the
      two types of lesions (radiographic vs clinically important) and feasibility of obtaining
      qbMRI in the setting of acute pediatric head trauma. While this study did not miss any
      clinically important TBIs, on further review of radiographic "missed lesions", the study
      pediatric neurosurgeon noted signs of a healing bleed. This may suggest that they were
      "missed" because they were healed rather than present and not seen. All patients that did not
      have a lesion identified on QbMRI did not require significant clinical interventions and only
      underwent periods of observation in the hospital. However, this raises the need for a
      prospective trial to obtain QbMRI imaging within the same time frame sequentially after the
      initial head CT.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives)
time frame: within 6 hours from the initial head CT
description: Sensitivity of Rapid MRI for detection of a clinically important intracranial injury: Percentage of MRIs identifying clinically important intracranial injury. Sensitivity was calculated as the number of true positives divided by "true positive plus false negative". True positive was defined based on meeting clinical criteria for a clinically important TBI and if the imaging found the injury.
measure: Time From Order to Obtaining MRI
time frame: During initial ER stay within 3 hours from time of entry to the ER
description: minutes
measure: Need for Anxiolysis Medication (Defined as Benzodiazepines for Imaging Indication)
time frame: During initial ER stay within 3 hours from time of entry to the ER
description: Number of patients requiring medication to obtain imaging
intervention type: Diagnostic Test
intervention name: Rapid Brain MRI
description: Children undergoing head CT for evaluation of acute head injury will also undergo rapid brain MRI with GRE sequence that is specific for blood. Their clinical care will not change at all based on the MRI.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 14 Years
last name: David Sheridan, MD MCR
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Dr. David Sheridan
investigator title: Assistant Professor of Emergency Medicine/Pediatrics
mesh term: Craniocerebral Trauma
mesh term: Wounds and Injuries
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 