<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/NCT04507113</url>
  </required_header>
  <id_info>
    <org_study_id>RC-P0074</org_study_id>
    <nct_id>NCT04507113</nct_id>
  </id_info>
  <brief_title>Diffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia</brief_title>
  <acronym>DiTi-Aïe</acronym>
  <official_title>Prognostic Value Assessment of Biomarkers in Acute Lumbar Radiculalgia : Contribution of the Diffusion Tensor in Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</source>
  <oversight_info>
    <has_dmc>No</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>
      Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach&#xD;
      that provides morphological information about the microstructures of the nerve roots. DTI is&#xD;
      a widely used neuroimaging technique and is a current topic of research in the field of&#xD;
      peripheral nerve imaging.The aim of the study is to determine the prognostic quality of the&#xD;
      DTI parameters to predict the therapeutic evolution of patients with lumbar radiculalgia at 6&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 1, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Predictive performance of DTI imaging on the therapeutic evolution</measure>
    <time_frame>6 months</time_frame>
    <description>DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.&#xD;
The objective is to know if the interpretation of DTI allow to predict the therapeutic evolution of patients. For instance, the patients will need in the future oral drugs? Or they will need rather an infiltration? Or they will need rather a surgery?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between DTI parameters and pain intensity</measure>
    <time_frame>6 months</time_frame>
    <description>DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.&#xD;
The intensity of pain will be self evaluated by the visual analogue scale (VAS). This scale is between 0 and 10 (in cms) being absence of pain and 10 intolerable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between DTI parameters evolution and neuropathic pain</measure>
    <time_frame>6 months</time_frame>
    <description>DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.&#xD;
The presence of neuropathic pain will be evaluated by the Neuropathic Pain Symptom Inventory (NPSI) scale. This is a self-questionnaire.The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between DTI parameters evolution and disability</measure>
    <time_frame>6 months</time_frame>
    <description>DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is a diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s. The disability will be measured by the Oswestry Disability Index (ODI). The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Lumbar Radiculopathy</condition>
  <condition>Magnetic Resonance Imaging</condition>
  <condition>Diffusion Tensor Imaging</condition>
  <arm_group>
    <arm_group_label>Lumbar radiculopathy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with acute lumbar radiculopathy (less than 3 months of evolution)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DTI sequence acquisition</intervention_name>
    <description>DTI sequence acquisition</description>
    <arm_group_label>Lumbar radiculopathy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 ans&#xD;
&#xD;
          -  Patient with Lumbar Radiculalgia (L4, L5 or S1)&#xD;
&#xD;
          -  Pain VAS (Visual analog scale) &gt; 30/100&#xD;
&#xD;
          -  Less than 3 months of evolution&#xD;
&#xD;
          -  With a radiculalgia superior or equal to lumbalgia&#xD;
&#xD;
          -  Disco radicular conflict, verified by MRI&#xD;
&#xD;
          -  Able to receive information&#xD;
&#xD;
          -  Affiliated to French social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chronic lumbalgia and radiculalgia&#xD;
&#xD;
          -  History of lumbar surgery&#xD;
&#xD;
          -  Recent episode (less than 6 months) with the same radicular topography&#xD;
&#xD;
          -  Bilateral radicular compression on MRI&#xD;
&#xD;
          -  Patient requiring emergency surgery&#xD;
&#xD;
          -  Evolutive disease interfering with pain assesment (neoplasia, inflammatory rheumatism,&#xD;
             peripheral neuropathy, central neurological disease)&#xD;
&#xD;
          -  MRI contraindication&#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>Jean-François BUDZIK, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lille CU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amélie LANSIAUX, MD, PhD</last_name>
    <phone>03.20.22.52.69</phone>
    <email>lansiaux.amelie@ghicl.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amel BOULAFA, Master</last_name>
    <phone>03.20.22.52.69</phone>
    <email>boulafa.amel@ghicl.net</email>
  </overall_contact_backup>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lumbar Radiculopathy</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Diffusion Tensor Imaging</keyword>
  <keyword>Prognostic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiculopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04507113
org study id: RC-P0074
nct id: NCT04507113
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach
      that provides morphological information about the microstructures of the nerve roots. DTI is
      a widely used neuroimaging technique and is a current topic of research in the field of
      peripheral nerve imaging.The aim of the study is to determine the prognostic quality of the
      DTI parameters to predict the therapeutic evolution of patients with lumbar radiculalgia at 6
      months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Predictive performance of DTI imaging on the therapeutic evolution
time frame: 6 months
description: DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.
The objective is to know if the interpretation of DTI allow to predict the therapeutic evolution of patients. For instance, the patients will need in the future oral drugs? Or they will need rather an infiltration? Or they will need rather a surgery?
measure: Correlation between DTI parameters and pain intensity
time frame: 6 months
description: DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.
The intensity of pain will be self evaluated by the visual analogue scale (VAS). This scale is between 0 and 10 (in cms) being absence of pain and 10 intolerable pain.
measure: Correlation between DTI parameters evolution and neuropathic pain
time frame: 6 months
description: DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s.
The presence of neuropathic pain will be evaluated by the Neuropathic Pain Symptom Inventory (NPSI) scale. This is a self-questionnaire.The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.
measure: Correlation between DTI parameters evolution and disability
time frame: 6 months
description: DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is a diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s. The disability will be measured by the Oswestry Disability Index (ODI). The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
arm group label: Lumbar radiculopathy
arm group type: Experimental
description: Patients with acute lumbar radiculopathy (less than 3 months of evolution)
intervention type: Other
intervention name: DTI sequence acquisition
description: DTI sequence acquisition
arm group label: Lumbar radiculopathy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-François BUDZIK, MD, PhD
role: Principal Investigator
affiliation: Lille CU
last name: Amélie LANSIAUX, MD, PhD
phone: 03.20.22.52.69
email: lansiaux.amelie@ghicl.net
last name: Amel BOULAFA, Master
phone: 03.20.22.52.69
email: boulafa.amel@ghicl.net
responsible party type: Sponsor
mesh term: Radiculopathy
sharing ipd: No