<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/NCT02217280</url>
  </required_header>
  <id_info>
    <org_study_id>1210810</org_study_id>
    <nct_id>NCT02217280</nct_id>
  </id_info>
  <brief_title>Dispersal Pattern for Spine Injections (Gadolinium Contrast)</brief_title>
  <official_title>Dispersal Pattern of Injectate After Cervical Epidural Steroid Evaluated With Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will analyze injectate dispersal patterns after standard-of-care cervical epidural&#xD;
      steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to&#xD;
      characterize the pattern. Although these procedures are performed with high frequency under&#xD;
      the assumption that injectate remains localized to injection site, no peer-reviewed studies&#xD;
      have validated this assumption. Comprehensive characterization of injectate dispersal&#xD;
      patterns will provide important data regarding safety, as well as diagnostic and therapeutic&#xD;
      potential of cervical epidural steroid injections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidural steroid injections have long had an impact in the treatment of various spine-related&#xD;
      conditions, particularly radiculopathy. The efficacy of epidural spinal injections has been&#xD;
      attributed to the anatomic location reached by the injectate. Cervical epidural steroid&#xD;
      injections are also used as an injury location indicator. This application is based on&#xD;
      documenting pain relief after injection into a specific location in the cervical spine. Both&#xD;
      the diagnostic and therapeutic applications for epidurals assume that the injectate remains&#xD;
      local to the injection site in order to have its effects. However, in a recently completed&#xD;
      study, the investigators group documented substantial diffusion of injectate after lumbar&#xD;
      epidurals used computerized tomography (CT) assessments.1 Based on the exposure to ionizing&#xD;
      radiation associated with CT along with the superior imaging specificity and sensitivity of&#xD;
      MRI, the investigators are shifting their imaging modality to MRI for future studies. The&#xD;
      proposed study is designed to evaluate the use of gadolinium and MRI to assess nature and&#xD;
      amount of diffusion of injectate in the cervical region after standard-of-care epidural&#xD;
      injections. To the investigators knowledge, this will be the first study to critically assess&#xD;
      this common procedure in order to evaluate safety and efficacy in a clinical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.</measure>
    <time_frame>1 hour</time_frame>
    <description>Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circumferential Contrast Spread</measure>
    <time_frame>1 hour</time_frame>
    <description>Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane.&#xD;
This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cervical Radiculopathy</condition>
  <arm_group>
    <arm_group_label>Injection with Gadolinium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Injection with Gadolinium</intervention_name>
    <description>Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system</description>
    <arm_group_label>Injection with Gadolinium</arm_group_label>
    <other_name>Gadavist</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-85&#xD;
&#xD;
          -  Cervical radiculopathy patient as identified by principle investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give consent or comply with rehabilitation process&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Co-morbidities such as infection, malignancy, myelopathy or an uncontrolled medical&#xD;
             condition&#xD;
&#xD;
          -  Allergy to injectate&#xD;
&#xD;
          -  Anticoagulative state&#xD;
&#xD;
          -  Severe claustrophobia&#xD;
&#xD;
          -  Non-MRI compatible pacemaker, neurostimulator, bladder stimulator or other mechanical&#xD;
             device&#xD;
&#xD;
          -  Renal disease that would cause the patient to be at an increased risk of complication&#xD;
             of receiving the contrast agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina L Goldstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri Department of Orthopaedics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Missouri Orthopaedic Institute</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>March 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>April 18, 2017</results_first_submitted>
  <results_first_submitted_qc>May 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2017</results_first_posted>
  <last_update_submitted>May 26, 2017</last_update_submitted>
  <last_update_submitted_qc>May 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Christina Goldstein</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cervical Radiculopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiculopathy</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cervical ESI With Gadolinium</title>
          <description>Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Post-consent sceen fail</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cervical ESI With Gadolinium</title>
          <description>Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="16"/>
                  </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>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.18" lower_limit="39" upper_limit="64"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.</title>
        <description>Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.</description>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Injection With Gadolinium</title>
            <description>This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.&#xD;
Injection with Gadolinium: Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system</description>
          </group>
        </group_list>
        <measure>
          <title>Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.</title>
          <description>Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.73" spread="3.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Circumferential Contrast Spread</title>
        <description>Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane.&#xD;
This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord).</description>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cervical ESI</title>
            <description>Male and female subjects between the ages of 18-85 with cervical radiculopathy. This was a single arm study.</description>
          </group>
        </group_list>
        <measure>
          <title>Circumferential Contrast Spread</title>
          <description>Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane.&#xD;
This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>Regular investigator assessment</desc>
      <group_list>
        <group group_id="E1">
          <title>Cervical ESI With Gadolinium</title>
          <description>Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.</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="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
              </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="16"/>
              </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>Dr. Christina Goldstein</name_or_title>
      <organization>Missouri Orthopaedic Institute</organization>
      <phone>573-884-9022</phone>
      <email>goldsteincl@health.missouri.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/NCT02217280
org study id: 1210810
nct id: NCT02217280
lead sponsor: 
has dmc: No
This study will analyze injectate dispersal patterns after standard-of-care cervical epidural
      steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to
      characterize the pattern. Although these procedures are performed with high frequency under
      the assumption that injectate remains localized to injection site, no peer-reviewed studies
      have validated this assumption. Comprehensive characterization of injectate dispersal
      patterns will provide important data regarding safety, as well as diagnostic and therapeutic
      potential of cervical epidural steroid injections.
Epidural steroid injections have long had an impact in the treatment of various spine-related
      conditions, particularly radiculopathy. The efficacy of epidural spinal injections has been
      attributed to the anatomic location reached by the injectate. Cervical epidural steroid
      injections are also used as an injury location indicator. This application is based on
      documenting pain relief after injection into a specific location in the cervical spine. Both
      the diagnostic and therapeutic applications for epidurals assume that the injectate remains
      local to the injection site in order to have its effects. However, in a recently completed
      study, the investigators group documented substantial diffusion of injectate after lumbar
      epidurals used computerized tomography (CT) assessments.1 Based on the exposure to ionizing
      radiation associated with CT along with the superior imaging specificity and sensitivity of
      MRI, the investigators are shifting their imaging modality to MRI for future studies. The
      proposed study is designed to evaluate the use of gadolinium and MRI to assess nature and
      amount of diffusion of injectate in the cervical region after standard-of-care epidural
      injections. To the investigators knowledge, this will be the first study to critically assess
      this common procedure in order to evaluate safety and efficacy in a clinical setting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.
time frame: 1 hour
description: Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.
measure: Circumferential Contrast Spread
time frame: 1 hour
description: Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane.
This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord).
arm group label: Injection with Gadolinium
arm group type: Experimental
description: This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.
intervention type: Drug
intervention name: Injection with Gadolinium
description: Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
arm group label: Injection with Gadolinium
other name: Gadavist
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Christina L Goldstein, MD
role: Principal Investigator
affiliation: University of Missouri Department of Orthopaedics
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Christina Goldstein
investigator title: Principal Investigator
mesh term: Radiculopathy
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 