<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/NCT01724216</url>
  </required_header>
  <id_info>
    <org_study_id>114-2012-GES-0014</org_study_id>
    <nct_id>NCT01724216</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging Using Innovative Pulse Sequences</brief_title>
  <official_title>Magnetic Resonance Imaging Using Innovative Pulse Sequences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GE Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to collect in vivo human image data to demonstrate neurological&#xD;
      magnetic resonance imaging (MRI) of subjects using short pulse sequences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-site; open-label, prospective research Study involving human subjects. There&#xD;
      will be no comparative efficacy or safety analysis and therefore no randomization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Head Images Successfully Collected</measure>
    <time_frame>6-months</time_frame>
    <description>Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Clinical Indication for a Head MRI</condition>
  <arm_group>
    <arm_group_label>pulse sequence software</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The central aim of this study is to acquire a set of images and associated technical and clinical information to facilitate regulatory submission of the pulse sequences being studied by GEHC. Segment 1 allows to collect a minimum of 10 subjects then evaluate if additional scans/enrollment needed Segment 2 will allow an additional 90 subjects if data needed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>pulse sequences</intervention_name>
    <description>Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence</description>
    <arm_group_label>pulse sequence software</arm_group_label>
    <other_name>zero TE pulse sequences</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be at least 18 years of age&#xD;
&#xD;
          -  Subject must be willing and able to undergo verbal and written informed consent&#xD;
&#xD;
          -  Subject must have a clinical indication for a head MRI with and without&#xD;
             Gadolinium-based contrast agent administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have any of the conditions below at the time of the enrollment or scan&#xD;
             session are excluded from this study. Further, should it be determined by study staff&#xD;
             that an enrolled subject meets any of the conditions below during the course of the&#xD;
             study, the subject will be removed from the study.&#xD;
&#xD;
               -  Any contraindication to an MRI scan per the policy of Spectrum Health&#xD;
&#xD;
               -  Any contraindication to administration of an MRI contrast agent per the policy of&#xD;
                  Spectrum Health&#xD;
&#xD;
               -  Off-label utilization of contrast agents administered for the subject's clinical&#xD;
                  exam&#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>Mark C DeLano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spectrum Health Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <results_first_submitted>October 22, 2013</results_first_submitted>
  <results_first_submitted_qc>August 25, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 2, 2014</results_first_posted>
  <last_update_submitted>October 15, 2015</last_update_submitted>
  <last_update_submitted_qc>October 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects with orders from their doctor for an MRI were screened from Spectrum Health's Neurology Department. The study coordinator contacts each subject that met the inclusion criteria. If the subject is interested to volunteer, a copy of the Informed Consent was sent and appointment scheduled. Seg. 1 enrolled 11 subjects; no Seg. 2 enrollment.</recruitment_details>
      <pre_assignment_details>This is a single arm study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Single Arm</title>
          <description>Magnetic Resonance Images Collected Using Innovative Pulse Sequences :</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Scan was not completed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>images collected</population>
      <group_list>
        <group group_id="B1">
          <title>Single Arm</title>
          <description>Magnetic Resonance Image Collection Using Innovative Pulse Sequences</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants with images collected</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;=18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants with images collected</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Gender was not a data point collected during the study.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>particpants with images collected</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Head Images Successfully Collected</title>
        <description>Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.</description>
        <time_frame>6-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Magnetic Resonance Imaging Using Innovative Pulse Sequences :</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Head Images Successfully Collected</title>
          <description>Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.</description>
          <units>Images</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Images</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Single Arm</title>
          <description>Magnetic Resonance Imaging Using Innovative Pulse Sequences :</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </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="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Mark Charles DeLano, M.D., Principal Investigator</name_or_title>
      <organization>Spectrum Health</organization>
      <phone>616-363-7339</phone>
      <email>delanom@msu.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/NCT01724216
org study id: 114-2012-GES-0014
nct id: NCT01724216
lead sponsor: 
has dmc: No
The purpose of the study is to collect in vivo human image data to demonstrate neurological
      magnetic resonance imaging (MRI) of subjects using short pulse sequences.
This is a single-site; open-label, prospective research Study involving human subjects. There
      will be no comparative efficacy or safety analysis and therefore no randomization
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Number of Head Images Successfully Collected
time frame: 6-months
description: Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.
arm group label: pulse sequence software
arm group type: Experimental
description: The central aim of this study is to acquire a set of images and associated technical and clinical information to facilitate regulatory submission of the pulse sequences being studied by GEHC. Segment 1 allows to collect a minimum of 10 subjects then evaluate if additional scans/enrollment needed Segment 2 will allow an additional 90 subjects if data needed
intervention type: Device
intervention name: pulse sequences
description: Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence
arm group label: pulse sequence software
other name: zero TE pulse sequences
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark C DeLano, MD
role: Principal Investigator
affiliation: Spectrum Health Hospitals
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 