<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/NCT03268239</url>
  </required_header>
  <id_info>
    <org_study_id>ALR_2017_11</org_study_id>
    <nct_id>NCT03268239</nct_id>
  </id_info>
  <brief_title>Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions</brief_title>
  <acronym>COGITE</acronym>
  <official_title>Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard&#xD;
      to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of&#xD;
      enhanced MRI to detect active lesions may vary according to the acquisition strategy used&#xD;
      (e.g., delay between injection and image acquisition, contrast dose, field strength, and&#xD;
      frequency of MRI sampling). Selection of the most appropriate T1-weighted sequence after&#xD;
      contrast injection may also influence sensitivity. Several clinical studies performed at 1.5&#xD;
      Tesla have shown that conventional 2D spin-echo (SE) sequences perform better than gradient&#xD;
      recalled-echo (GRE) sequences for depicting active MS lesions after gadolinium injection. As&#xD;
      relates to MS, 3.0 Tesla systems offer some advantages over lower field strengths, such as&#xD;
      higher detection rates for T2 and gadolinium-enhancing brain lesions, an important capability&#xD;
      for diagnosing and monitoring MS patients. Recent studies have shown that at 3 Tesla, 3D GRE&#xD;
      or 3D fast SE sequences provide higher detection rates for gadolinium-enhancing MS lesions,&#xD;
      especially smaller ones, than standard 2D SE, and better suppress artefacts related to&#xD;
      vascular pulsation. However, the comparison of the performance of 3D GRE versus 3D SE&#xD;
      sequences has not been investigated yet.&#xD;
&#xD;
      Objectives To compare the sensitivity of enhancing multiple sclerosis (MS) lesions in&#xD;
      gadolinium-enhanced 3D T1-weighted gradient-echo (GRE) and turbo-spin-echo (TSE) sequences.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">April 26, 2021</completion_date>
  <primary_completion_date type="Actual">April 26, 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>Number of gadolinium-enhanced brain lesions</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of gadolinium-enhanced brain lesions depicted on a 3D T1 Turbo Spin Echo sequence compared to those depicted on the 3D T1 Gradient-Recalled Echo sequence.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Magnetic Resonance Imaging</condition>
  <condition>Central Nervous System</condition>
  <condition>Brain</condition>
  <condition>Multiple Sclerosis</condition>
  <condition>Demyelinating Diseases</condition>
  <arm_group>
    <arm_group_label>MRI sequences</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>There will be only one arm of patients with central nervous system inflammatory disease.&#xD;
Each patient will be its own control. The usual and additional MRI sequences will be performed in all patients and the number of lesions obtained in usual sequences and additional sequences will be compared in the same patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Additional MRI sequences</intervention_name>
    <description>Due to the participation in the study, the following sequences are added to the imaging protocol:&#xD;
3D T1 GRE after injection (Gradient-Recalled Echo)&#xD;
3D T1 TSE before injection (Turbo Spin Echo)&#xD;
3D fGATIR PSIR after injection (fast Gray Matter Acquisition T1 Inversion Recovery Phase-Sensitive Inversion Recovery)&#xD;
Sequences will be performed in a random order to avoid the bias induced by different time intervals between injection and acquisition.</description>
    <arm_group_label>MRI sequences</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Equal or more than 18 years of age&#xD;
&#xD;
          -  Able to provide written informed consent.&#xD;
&#xD;
          -  Known central nervous system inflammatory disease&#xD;
&#xD;
          -  Magnetic Resonance exam needed for evaluation after a clinical event in the last 3&#xD;
             weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current treatment with dimethylfumarate (Tecfidera®), natalizumab (Tysabri®) or&#xD;
             fingolimod (Gilenya®)&#xD;
&#xD;
          -  Contraindications either to 3 Tesla Magnetic Resonance Imaging (e.g. certain metallic&#xD;
             and electronic implants, claustrophobia) or IV gadolinium contrast (allergy,&#xD;
             pregnancy, breast-feeding, renal insufficiency).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fondation Ophtalmologique A. de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2021</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>Multiple Sclerosis</mesh_term>
    <mesh_term>Demyelinating Diseases</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03268239
org study id: ALR_2017_11
nct id: NCT03268239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard
      to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of
      enhanced MRI to detect active lesions may vary according to the acquisition strategy used
      (e.g., delay between injection and image acquisition, contrast dose, field strength, and
      frequency of MRI sampling). Selection of the most appropriate T1-weighted sequence after
      contrast injection may also influence sensitivity. Several clinical studies performed at 1.5
      Tesla have shown that conventional 2D spin-echo (SE) sequences perform better than gradient
      recalled-echo (GRE) sequences for depicting active MS lesions after gadolinium injection. As
      relates to MS, 3.0 Tesla systems offer some advantages over lower field strengths, such as
      higher detection rates for T2 and gadolinium-enhancing brain lesions, an important capability
      for diagnosing and monitoring MS patients. Recent studies have shown that at 3 Tesla, 3D GRE
      or 3D fast SE sequences provide higher detection rates for gadolinium-enhancing MS lesions,
      especially smaller ones, than standard 2D SE, and better suppress artefacts related to
      vascular pulsation. However, the comparison of the performance of 3D GRE versus 3D SE
      sequences has not been investigated yet.

      Objectives To compare the sensitivity of enhancing multiple sclerosis (MS) lesions in
      gadolinium-enhanced 3D T1-weighted gradient-echo (GRE) and turbo-spin-echo (TSE) sequences.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of gadolinium-enhanced brain lesions
time frame: Baseline
description: Number of gadolinium-enhanced brain lesions depicted on a 3D T1 Turbo Spin Echo sequence compared to those depicted on the 3D T1 Gradient-Recalled Echo sequence.
arm group label: MRI sequences
arm group type: Other
description: There will be only one arm of patients with central nervous system inflammatory disease.
Each patient will be its own control. The usual and additional MRI sequences will be performed in all patients and the number of lesions obtained in usual sequences and additional sequences will be compared in the same patient.
intervention type: Device
intervention name: Additional MRI sequences
description: Due to the participation in the study, the following sequences are added to the imaging protocol:
3D T1 GRE after injection (Gradient-Recalled Echo)
3D T1 TSE before injection (Turbo Spin Echo)
3D fGATIR PSIR after injection (fast Gray Matter Acquisition T1 Inversion Recovery Phase-Sensitive Inversion Recovery)
Sequences will be performed in a random order to avoid the bias induced by different time intervals between injection and acquisition.
arm group label: MRI sequences
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Demyelinating Diseases
mesh term: Sclerosis
sharing ipd: Undecided