<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/NCT03800537</url>
  </required_header>
  <id_info>
    <org_study_id>18-2071</org_study_id>
    <nct_id>NCT03800537</nct_id>
  </id_info>
  <brief_title>MR Fingerprinting: A Novel Sequence Applied to Neuroimaging</brief_title>
  <official_title>MR Fingerprinting: A Novel Sequence Applied to Neuroimaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Magnetic Resonance Imaging (MRI) has become one of most important medical imaging tools over&#xD;
      the past 30 years because it is non-invasive, requires no ionizing radiation, and provides&#xD;
      exquisite images of soft tissues and anatomic structures with many tissue/disease specific&#xD;
      contrasts. While MRI has served the community well for many years, it is increasingly clear&#xD;
      that it also has significant limitations.&#xD;
&#xD;
      One of the principle limitations is the lack of quantitative information for tissue/structure&#xD;
      characterization. The current paradigm of MRI is to use a set of scanner settings to generate&#xD;
      an image &quot;weighted&quot; by a specific MR contrast mechanism (physical parameter), where it is&#xD;
      hoped that variations in the parameter will be accentuated. However, without quantitative&#xD;
      knowledge of the parameters, the final image contrast may depend on many factors, which&#xD;
      complicates image interpretation and diagnostic performance. Quantitative measurement can&#xD;
      provide a great deal of information about tissue properties and pathological conditions,&#xD;
      since these parameters ultimately determine the contrast that is observed in conventional&#xD;
      images.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate novel quantitative MRI techniques in clinical&#xD;
      studies to determine whether they can provide better, faster and more useful information for&#xD;
      clinical diagnosis. Quantitative MRI has been a continuous interest in the MRI community, but&#xD;
      extremely challenging due to long acquisition times and sensitivity to motion. Recently, the&#xD;
      investigators have introduced a novel MRI data acquisition approach, namely MR Fingerprinting&#xD;
      (MRF), for simultaneous measurement of several important parameters in a single MRI scan.&#xD;
&#xD;
      In this study, the investigators propose to apply MR Fingerprinting at UNC and evaluate its&#xD;
      performance for different neurological diseases. The investigators hypothesize that the&#xD;
      quantitative MR imaging technique will lead to improved tissue characterization and&#xD;
      diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">August 18, 2022</completion_date>
  <primary_completion_date type="Actual">August 18, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Participants With Visible Region of Interest (Imaging Visibility)</measure>
    <time_frame>Immediately following MRI completion, within approximately 5 minutes</time_frame>
    <description>Magnetic Resonance (MR) fingerprinting sequences will be examined to determine their utility for visualizing pathology.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Disease;Neurological</condition>
  <arm_group>
    <arm_group_label>All Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive the investigational MR Fingerprinting sequence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MR Fingerprinting</intervention_name>
    <description>The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study will include English-speaking patients that are already scheduled to undergo&#xD;
             a clinical neurological MRI for diagnostic purposes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yueh Z Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>May 19, 2023</results_first_submitted>
  <results_first_submitted_qc>May 19, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 12, 2023</results_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2023</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>Nervous System Diseases</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_info_type>Study Protocol</ipd_info_type>
    <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 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_access_criteria>
  </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>April 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03800537/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>December 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03800537/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>All participants will receive the investigational MR Fingerprinting sequence.&#xD;
MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </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="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All participants will receive the investigational MR Fingerprinting sequence.&#xD;
MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Participants With Visible Region of Interest (Imaging Visibility)</title>
        <description>Magnetic Resonance (MR) fingerprinting sequences will be examined to determine their utility for visualizing pathology.</description>
        <time_frame>Immediately following MRI completion, within approximately 5 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants will receive the investigational MR Fingerprinting sequence.&#xD;
MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Visible Region of Interest (Imaging Visibility)</title>
          <description>Magnetic Resonance (MR) fingerprinting sequences will be examined to determine their utility for visualizing pathology.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</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="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the standard of care MRI and including the investigational MRI sequence, a total of up to approximately 25 minutes.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>All participants will receive the investigational MR Fingerprinting sequence.&#xD;
MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.</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="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </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="14"/>
              </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>Desma Jones</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-843-9463</phone>
      <email>desma_jones@med.unc.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/NCT03800537
org study id: 18-2071
nct id: NCT03800537
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Magnetic Resonance Imaging (MRI) has become one of most important medical imaging tools over
      the past 30 years because it is non-invasive, requires no ionizing radiation, and provides
      exquisite images of soft tissues and anatomic structures with many tissue/disease specific
      contrasts. While MRI has served the community well for many years, it is increasingly clear
      that it also has significant limitations.

      One of the principle limitations is the lack of quantitative information for tissue/structure
      characterization. The current paradigm of MRI is to use a set of scanner settings to generate
      an image "weighted" by a specific MR contrast mechanism (physical parameter), where it is
      hoped that variations in the parameter will be accentuated. However, without quantitative
      knowledge of the parameters, the final image contrast may depend on many factors, which
      complicates image interpretation and diagnostic performance. Quantitative measurement can
      provide a great deal of information about tissue properties and pathological conditions,
      since these parameters ultimately determine the contrast that is observed in conventional
      images.
The purpose of this study is to evaluate novel quantitative MRI techniques in clinical
      studies to determine whether they can provide better, faster and more useful information for
      clinical diagnosis. Quantitative MRI has been a continuous interest in the MRI community, but
      extremely challenging due to long acquisition times and sensitivity to motion. Recently, the
      investigators have introduced a novel MRI data acquisition approach, namely MR Fingerprinting
      (MRF), for simultaneous measurement of several important parameters in a single MRI scan.

      In this study, the investigators propose to apply MR Fingerprinting at UNC and evaluate its
      performance for different neurological diseases. The investigators hypothesize that the
      quantitative MR imaging technique will lead to improved tissue characterization and
      diagnosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percent of Participants With Visible Region of Interest (Imaging Visibility)
time frame: Immediately following MRI completion, within approximately 5 minutes
description: Magnetic Resonance (MR) fingerprinting sequences will be examined to determine their utility for visualizing pathology.
arm group label: All Participants
arm group type: Experimental
description: All participants will receive the investigational MR Fingerprinting sequence.
intervention type: Device
intervention name: MR Fingerprinting
description: The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.
arm group label: All Participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Yueh Z Lee, MD, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nervous System Diseases
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 info type: Study Protocol
ipd time frame: 9 to 36 months following publication
ipd access criteria: 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.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 