<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/NCT03274037</url>
  </required_header>
  <id_info>
    <org_study_id>IDRCB: 2013-A00289-36</org_study_id>
    <nct_id>NCT03274037</nct_id>
  </id_info>
  <brief_title>Evaluation of Cerebral Elastography by Magnetic Resonance: Comparison of Healthy Subjects and Patients With Glial Tumor</brief_title>
  <acronym>g-BrainMRE</acronym>
  <official_title>The Relevance of Cerebral MRI Elastography in the Mechanical Characterization of Glial Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      MRI elastography detects the movement of tissues in the human body and monitors their&#xD;
      response to mechanical stress in order to reveal their mechanical properties, like palpation.&#xD;
      These depend on the structure of the tissues, their biological conditions and possible&#xD;
      conditions. This non-invasive technique allows exploration of deep organs such as the brain&#xD;
      that the doctor's hand can not reach. MRI elastography may prove to be an essential tool for&#xD;
      study, diagnosis, staging and therapeutic monitoring of brain diseases.&#xD;
&#xD;
      Neurodegenerative diseases (Alzheimer's, Parkinson's, Creutzfeldt-Jakobes) and cancers&#xD;
      largely modify the mechanical properties of the affected tissues. For a first evaluation of&#xD;
      the technique, we are interested in glial tumors representing half of the intracranial tumors&#xD;
      in adults (incidence: 5 cases per 100 000 inhabitants), the second cancer in children and the&#xD;
      third cause of death in l Young adult.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Initiated in 1996, magnetic resonance elastography detects the movement of tissues in the&#xD;
      human body and monitors their response to mechanical stress in order to reveal their&#xD;
      mechanical properties. These depend on the structure of the tissues, their biological&#xD;
      conditions and the possible affections affecting them,. This technique, with recognized&#xD;
      safety, allows us to replace the doctor's usual palpation of peripheral organs, such as the&#xD;
      liver, or the breast, and to consider the exploration of deeper organs such as the heart or&#xD;
      the brain ,. At the Bicêtre Inter-Establishment Center, under the direction of Ralph Sinkus&#xD;
      of the Beaujon Hospital, the elastography of breast7 (for the exploration of tumors) and of&#xD;
      the heart9 is already being studied . At the Hôpital de Beaujon, elastography was developed&#xD;
      to study tumors, fibrosis and cirrhosis of the liver5. Through a vibrating bar, Mayo&#xD;
      Clinic11, in the United States, then, in an oscillating cradle, Charity12, Germany, induced&#xD;
      waves in the human brain and early measurements of the brain's elastography showed a&#xD;
      Significant difference in the modulus of elasticity and viscosity of the white matter and the&#xD;
      gray matter. The dependence of these modules on age and gender was discussed.&#xD;
&#xD;
      The elasticity measured by MRI of tumors of 38 to 75 mm in diameter could also be correlated&#xD;
      with the tissue consistency of the samples obtained during a surgical reduction. Finally, in&#xD;
      a patient with a temporal glioma, the mean modulus of elasticity in the tumor region was&#xD;
      measured by elastography close to 30% greater than in the corresponding region of the healthy&#xD;
      hemisphere.&#xD;
&#xD;
      But the difficulty of introducing a mechanical wave into the brain through the cranial&#xD;
      chamber and the surrounding cerebro-spinal fluid limits the scope of the advanced results,&#xD;
      which are essentially qualitative at the moment. The median amplitude of the displacements&#xD;
      measured in the brain during these studies is only 7.33 μm at 40 Hz and drops to 2.70 μm at&#xD;
      120 Hz while it is more than 21 μm in the Liver and breast at 75 and 90 Hz respectively4.&#xD;
      Recently, the IR4M has developed an original excitation device that allows to circumvent this&#xD;
      limit. Displacements of cerebral tissues of several tens of micrometers have been reported by&#xD;
      MRI and the inversion of the problem leading to the viscoelastic modules could be carried out&#xD;
      on the whole of the human brain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 7, 2017</start_date>
  <completion_date type="Anticipated">July 7, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 7, 2020</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>normal values of cerebral MRI elastography in healthy volunteers</measure>
    <time_frame>1 month</time_frame>
    <description>Mechanical excitation by pressure waves</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Values of shear modulus of elasticity in the brain region explored</measure>
    <time_frame>1 month</time_frame>
    <description>Mechanical excitation by pressure waves</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Values of shear viscosity modulus according to the explored region of the brain</measure>
    <time_frame>1 month</time_frame>
    <description>Mechanical excitation by pressure waves</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Elasticity Imaging Techniques</condition>
  <arm_group>
    <arm_group_label>Examination of cerebral MRI elastography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The mechanical waves will be induced by pressure waves guided to the mouth of the elongated subject in the MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Device for mechanical excitation by pressure waves</intervention_name>
    <description>The IRM elastography technique, proven and patented in 2010 by the IR4M (Orsay, France), consists in characterizing by IRM induced waves in the human body in order to determine the mechanical properties Of the target organ.&#xD;
The mechanical waves will be induced by pressure waves guided at the mouth of the subject elongated in the MRI and consisting of a function generator at a frequency between 5 Hz and 500 Hz, linear amplifier , An electromechanical transducer, a waveguide whose length is adapted to the chosen excitation frequency, an antibacterial filter and a disposable mouthpiece&#xD;
The MRI imager Achieva 1.5 T MRI (Philips Healthcare, Best, the Netherlands) and the SIGNA Architect GEM 3.0T (GE medical systems, LLC, USA) system will be used to measure brain tissue displacement fields.</description>
    <arm_group_label>Examination of cerebral MRI elastography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for healthy subjects will be:&#xD;
&#xD;
          -  Age between 18 and 65 years&#xD;
&#xD;
          -  Ability to hold in an MRI device without moving&#xD;
&#xD;
          -  No known and diagnosed neurological pathologies such as stroke, cerebral surgery,&#xD;
             central nervous system tumor, inflammatory disease (such as multiple sclerosis),&#xD;
             neurodegenerative disease (such as Alzheimer's, Parkinson's or Creutzfeldt-Jakobes's&#xD;
             ), depression&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Inclusion criteria for patients will be:&#xD;
&#xD;
          -  Age between 18 and 65 years&#xD;
&#xD;
          -  Ability to hold in an MRI device without moving&#xD;
&#xD;
          -  Glial tumor greater than 3 mm diagnosed by standard MRI&#xD;
&#xD;
          -  Informed and informed consent&#xD;
&#xD;
        Exclusion Criteriafor both patients and healthy subjects will be:&#xD;
&#xD;
          -  Inability to perform an MRI examination : claustrophobia, presence of ferromagnetic&#xD;
             metallic foreign bodies, wearing a pace-maker, metallic cardiac prosthetic valve,&#xD;
             cochlear implants, vascular clips, insulin pump, pregnancy, breastfeeding..&#xD;
&#xD;
               -  Non-affiliation to a social security scheme (beneficiary or beneficiary)&#xD;
&#xD;
               -  Intercurrent disorder likely to disrupt test results&#xD;
&#xD;
               -  Patient under anticoagulant:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denis MD DUCREUX, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance publique des hopitaux de paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denis MD DUCREUX, PhD</last_name>
    <phone>01 45 21 33 88</phone>
    <email>denis.ducreux@bct.aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xavier MD MAITRE, PhD</last_name>
    <phone>01 69 15 41 34</phone>
    <email>xavier.maitre@u-psud.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Denis DUCREUX</name>
      <address>
        <city>Kremlin BICETRE</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denis MD DUCREUX, PhD</last_name>
      <phone>01 45 21 33 88</phone>
      <email>denis.ducreux@bct.aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</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>Glioma</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/NCT03274037
org study id: IDRCB: 2013-A00289-36
nct id: NCT03274037
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
MRI elastography detects the movement of tissues in the human body and monitors their
      response to mechanical stress in order to reveal their mechanical properties, like palpation.
      These depend on the structure of the tissues, their biological conditions and possible
      conditions. This non-invasive technique allows exploration of deep organs such as the brain
      that the doctor's hand can not reach. MRI elastography may prove to be an essential tool for
      study, diagnosis, staging and therapeutic monitoring of brain diseases.

      Neurodegenerative diseases (Alzheimer's, Parkinson's, Creutzfeldt-Jakobes) and cancers
      largely modify the mechanical properties of the affected tissues. For a first evaluation of
      the technique, we are interested in glial tumors representing half of the intracranial tumors
      in adults (incidence: 5 cases per 100 000 inhabitants), the second cancer in children and the
      third cause of death in l Young adult.
Initiated in 1996, magnetic resonance elastography detects the movement of tissues in the
      human body and monitors their response to mechanical stress in order to reveal their
      mechanical properties. These depend on the structure of the tissues, their biological
      conditions and the possible affections affecting them,. This technique, with recognized
      safety, allows us to replace the doctor's usual palpation of peripheral organs, such as the
      liver, or the breast, and to consider the exploration of deeper organs such as the heart or
      the brain ,. At the Bicêtre Inter-Establishment Center, under the direction of Ralph Sinkus
      of the Beaujon Hospital, the elastography of breast7 (for the exploration of tumors) and of
      the heart9 is already being studied . At the Hôpital de Beaujon, elastography was developed
      to study tumors, fibrosis and cirrhosis of the liver5. Through a vibrating bar, Mayo
      Clinic11, in the United States, then, in an oscillating cradle, Charity12, Germany, induced
      waves in the human brain and early measurements of the brain's elastography showed a
      Significant difference in the modulus of elasticity and viscosity of the white matter and the
      gray matter. The dependence of these modules on age and gender was discussed.

      The elasticity measured by MRI of tumors of 38 to 75 mm in diameter could also be correlated
      with the tissue consistency of the samples obtained during a surgical reduction. Finally, in
      a patient with a temporal glioma, the mean modulus of elasticity in the tumor region was
      measured by elastography close to 30% greater than in the corresponding region of the healthy
      hemisphere.

      But the difficulty of introducing a mechanical wave into the brain through the cranial
      chamber and the surrounding cerebro-spinal fluid limits the scope of the advanced results,
      which are essentially qualitative at the moment. The median amplitude of the displacements
      measured in the brain during these studies is only 7.33 μm at 40 Hz and drops to 2.70 μm at
      120 Hz while it is more than 21 μm in the Liver and breast at 75 and 90 Hz respectively4.
      Recently, the IR4M has developed an original excitation device that allows to circumvent this
      limit. Displacements of cerebral tissues of several tens of micrometers have been reported by
      MRI and the inversion of the problem leading to the viscoelastic modules could be carried out
      on the whole of the human brain
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: normal values of cerebral MRI elastography in healthy volunteers
time frame: 1 month
description: Mechanical excitation by pressure waves
measure: Values of shear modulus of elasticity in the brain region explored
time frame: 1 month
description: Mechanical excitation by pressure waves
measure: Values of shear viscosity modulus according to the explored region of the brain
time frame: 1 month
description: Mechanical excitation by pressure waves
arm group label: Examination of cerebral MRI elastography
arm group type: Experimental
description: The mechanical waves will be induced by pressure waves guided to the mouth of the elongated subject in the MRI
intervention type: Diagnostic Test
intervention name: Device for mechanical excitation by pressure waves
description: The IRM elastography technique, proven and patented in 2010 by the IR4M (Orsay, France), consists in characterizing by IRM induced waves in the human body in order to determine the mechanical properties Of the target organ.
The mechanical waves will be induced by pressure waves guided at the mouth of the subject elongated in the MRI and consisting of a function generator at a frequency between 5 Hz and 500 Hz, linear amplifier , An electromechanical transducer, a waveguide whose length is adapted to the chosen excitation frequency, an antibacterial filter and a disposable mouthpiece
The MRI imager Achieva 1.5 T MRI (Philips Healthcare, Best, the Netherlands) and the SIGNA Architect GEM 3.0T (GE medical systems, LLC, USA) system will be used to measure brain tissue displacement fields.
arm group label: Examination of cerebral MRI elastography
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Denis MD DUCREUX, PhD
role: Principal Investigator
affiliation: Assistance publique des hopitaux de paris
last name: Denis MD DUCREUX, PhD
phone: 01 45 21 33 88
email: denis.ducreux@bct.aphp.fr
last name: Xavier MD MAITRE, PhD
phone: 01 69 15 41 34
email: xavier.maitre@u-psud.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Glioma