<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/NCT03287596</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2015/16</org_study_id>
    <nct_id>NCT03287596</nct_id>
  </id_info>
  <brief_title>Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at 3T MRI</brief_title>
  <acronym>SILENZ</acronym>
  <official_title>Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at3T MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General Electric</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      The purpose of this study is to accurately map calcaneal fibrocartilage using TE = 0 ms&#xD;
      imaging, and then apply measurements of our control population to SpA patients with&#xD;
      peripheral enthesis study using the calcaneal tendon as a clinical model&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The human body contains a lot of tissue components with short T2 (transversal relaxation&#xD;
      time) that are not or only poorly detected on conventional T2-weighted MR sequences. These&#xD;
      components are mostly located in musculoskeletal organs such as tendons, ligaments, menisci,&#xD;
      periosteum or cortical bone.&#xD;
&#xD;
      Considering that conventional sequences do not detect tissue components with T2 shorter than&#xD;
      10ms, imaging of body tendon or enthesis is therefore very limited. This represents a&#xD;
      limitation of MR imaging in early diagnosis of a certain number of pathologies, such as&#xD;
      mechanical or mostly inflammatory tendinopathy or enthesopathy.&#xD;
&#xD;
      This study, would provide the feasibility of ZTE 2 sequence to quantitatively assess normal&#xD;
      and pathological spondyloarthropathy Achilles tendon enthesis at 3 T, and would demonstrate&#xD;
      that this sequence allows the detection of SpA enthesopathy prior to conventional sequences&#xD;
      and enables disease monitoring.&#xD;
&#xD;
      For those purposes, during inclusion visit sequences ZTE 2 and UTE (with and without&#xD;
      gadolinium injection) will be add to routine macrocyclic gadolinium injected MRI of 3 groups&#xD;
      of patients (symptomatic and non sympatomatic spondyloarthropathy and mechanical&#xD;
      tendinopathy). Healthy volunteer group will undergo an MRI exam without gadolinium injection&#xD;
      comprised of following sequences T2 FS, T1, DP FS, ZTE 2 and UTE.&#xD;
&#xD;
      No follow up visit are schedule in this study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2018</start_date>
  <completion_date type="Actual">January 21, 2023</completion_date>
  <primary_completion_date type="Actual">January 21, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum ZTE signal value in healthy volunteers</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum difference of the ZTE signal value between healthy volunteers and non-symptomatic SpA + patients in the calcaneal fibrocartilage</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum difference of the ZTE signal value between healthy volunteers and symptomatic SpA + patients in the calcaneal fibrocartilage</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum difference in the ZTE signal value between healthy volunteers and patients with mechanical tendinopathy</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Spondyloarthropathy</condition>
  <condition>Tendinopathy</condition>
  <arm_group>
    <arm_group_label>HEALTHY VOLUNTEERS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3D sequence ZTE2 DP without gadolinium&#xD;
3D Sequence UTE without gadolinium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPA + NON-SYMPTOMATICS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3D sequence ZTE2 DP without gadolinium&#xD;
3D Sequence UTE without gadolinium&#xD;
3D Sequence ZTE2 DP with gadolinium&#xD;
3D sequence UTE with gadolinium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPA + SYMPTOMATICS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3D sequence ZTE2 DP without gadolinium&#xD;
3D Sequence UTE without gadolinium&#xD;
3D Sequence ZTE2 DP with gadolinium&#xD;
3D sequence UTE with gadolinium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MECHANIC TENDINOPATHY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3D sequence ZTE2 DP without gadolinium&#xD;
3D Sequence UTE without gadolinium&#xD;
3D Sequence ZTE2 DP with gadolinium&#xD;
3D sequence UTE with gadolinium</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI ZTE2 sequence</intervention_name>
    <description>feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy</description>
    <arm_group_label>HEALTHY VOLUNTEERS</arm_group_label>
    <arm_group_label>MECHANIC TENDINOPATHY</arm_group_label>
    <arm_group_label>SPA + NON-SYMPTOMATICS</arm_group_label>
    <arm_group_label>SPA + SYMPTOMATICS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years,&#xD;
&#xD;
          -  Covered under social security&#xD;
&#xD;
          -  Informed signed consent&#xD;
&#xD;
        Additional criteria for each group:&#xD;
&#xD;
        GROUP 1: HEALTHY VOLUNTEERS&#xD;
&#xD;
          -  Absence of diagnosis of spondyloarthropathies&#xD;
&#xD;
          -  No previous history of plantar support and pain, calcaneal tendinopathy, infiltration&#xD;
             or surgery&#xD;
&#xD;
        GROUP 2: SPA + NON-SYMPTOMATICS AT THE CALCANEEN FIBROCARTILAGE LEVEL&#xD;
&#xD;
          -  ASAS criteria axial or appendicular&#xD;
&#xD;
          -  No previous history of plantar support and pain, infiltration or surgery&#xD;
&#xD;
          -  Prescription Achile's tendon MRI with injection of contrast agent (macrocyclic&#xD;
             gadolinium) in usual care.&#xD;
&#xD;
        GROUP 3: SPA + SYMPTOMATICS AT THE CALCANEEN FIBROCARTILAGE LEVEL&#xD;
&#xD;
          -  ASAS criteria axial or appendicular&#xD;
&#xD;
          -  Clinical suspicion of rheumatic enthesopathy&#xD;
&#xD;
          -  Absence of a history of calcaneal infiltration or surgery&#xD;
&#xD;
          -  Prescription Achile's tendon MRI with injection of contrast agent (macrocyclic&#xD;
             gadolinium) in usual care.&#xD;
&#xD;
        GROUP 4: MECHANIC TENDINOPATHY&#xD;
&#xD;
          -  Clinical diagnosis of calcaneal mechanical tendinopathy&#xD;
&#xD;
          -  Absence of diagnosis of spondyloarthropathies&#xD;
&#xD;
          -  No any previous history of plantar support disorder, calcaneal infiltration or surgery&#xD;
&#xD;
          -  Prescription Achile's tendon MRI with injection of contrast agent (macrocyclic&#xD;
             gadolinium) in usual care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 yrs old&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
&#xD;
          -  History or presence coronary pathology&#xD;
&#xD;
          -  Septic arthritis&#xD;
&#xD;
          -  Immunodeficiency.&#xD;
&#xD;
          -  Contra-indication for MRI exam&#xD;
&#xD;
          -  Legal protection&#xD;
&#xD;
        Additional criteria for GROUPS 2, 3 and 4:&#xD;
&#xD;
          -  History or presence of renal insufficiency&#xD;
&#xD;
          -  Allergy to macrocyclic gadolinium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier Hauger, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spondylarthropathy</keyword>
  <keyword>Tendinopathy</keyword>
  <keyword>MRI</keyword>
  <keyword>Healthy Volunteer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Spondylarthropathies</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03287596
org study id: CHUBX 2015/16
nct id: NCT03287596
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to accurately map calcaneal fibrocartilage using TE = 0 ms
      imaging, and then apply measurements of our control population to SpA patients with
      peripheral enthesis study using the calcaneal tendon as a clinical model
The human body contains a lot of tissue components with short T2 (transversal relaxation
      time) that are not or only poorly detected on conventional T2-weighted MR sequences. These
      components are mostly located in musculoskeletal organs such as tendons, ligaments, menisci,
      periosteum or cortical bone.

      Considering that conventional sequences do not detect tissue components with T2 shorter than
      10ms, imaging of body tendon or enthesis is therefore very limited. This represents a
      limitation of MR imaging in early diagnosis of a certain number of pathologies, such as
      mechanical or mostly inflammatory tendinopathy or enthesopathy.

      This study, would provide the feasibility of ZTE 2 sequence to quantitatively assess normal
      and pathological spondyloarthropathy Achilles tendon enthesis at 3 T, and would demonstrate
      that this sequence allows the detection of SpA enthesopathy prior to conventional sequences
      and enables disease monitoring.

      For those purposes, during inclusion visit sequences ZTE 2 and UTE (with and without
      gadolinium injection) will be add to routine macrocyclic gadolinium injected MRI of 3 groups
      of patients (symptomatic and non sympatomatic spondyloarthropathy and mechanical
      tendinopathy). Healthy volunteer group will undergo an MRI exam without gadolinium injection
      comprised of following sequences T2 FS, T1, DP FS, ZTE 2 and UTE.

      No follow up visit are schedule in this study
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Maximum ZTE signal value in healthy volunteers
time frame: baseline
measure: Maximum difference of the ZTE signal value between healthy volunteers and non-symptomatic SpA + patients in the calcaneal fibrocartilage
time frame: baseline
measure: Maximum difference of the ZTE signal value between healthy volunteers and symptomatic SpA + patients in the calcaneal fibrocartilage
time frame: baseline
measure: Maximum difference in the ZTE signal value between healthy volunteers and patients with mechanical tendinopathy
time frame: baseline
arm group label: HEALTHY VOLUNTEERS
arm group type: Experimental
description: 3D sequence ZTE2 DP without gadolinium
3D Sequence UTE without gadolinium
arm group label: SPA + NON-SYMPTOMATICS
arm group type: Experimental
description: 3D sequence ZTE2 DP without gadolinium
3D Sequence UTE without gadolinium
3D Sequence ZTE2 DP with gadolinium
3D sequence UTE with gadolinium
arm group label: SPA + SYMPTOMATICS
arm group type: Experimental
description: 3D sequence ZTE2 DP without gadolinium
3D Sequence UTE without gadolinium
3D Sequence ZTE2 DP with gadolinium
3D sequence UTE with gadolinium
arm group label: MECHANIC TENDINOPATHY
arm group type: Experimental
description: 3D sequence ZTE2 DP without gadolinium
3D Sequence UTE without gadolinium
3D Sequence ZTE2 DP with gadolinium
3D sequence UTE with gadolinium
intervention type: Device
intervention name: MRI ZTE2 sequence
description: feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy
arm group label: HEALTHY VOLUNTEERS
arm group label: MECHANIC TENDINOPATHY
arm group label: SPA + NON-SYMPTOMATICS
arm group label: SPA + SYMPTOMATICS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Olivier Hauger, MD, Ph.D
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Tendinopathy
mesh term: Spondylarthropathies
mesh term: Spondylarthritis