<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/NCT04417868</url>
  </required_header>
  <id_info>
    <org_study_id>7560</org_study_id>
    <nct_id>NCT04417868</nct_id>
  </id_info>
  <brief_title>Evolution of Cochleovestibular Schwannomas</brief_title>
  <official_title>Evolution of Cochleovestibular Schwannomas in the Internal Auditory Canal by Volume Measering With aTeslas MRI 3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Investigators want to know the natural history of the vestibular schwannomas: increasing,&#xD;
      decreasing or stability, by monitoring more than 3 MRIs during a span of more than 2 years.&#xD;
      They will obtain 3 groups: the volume increasing schwannomas which will be the most important&#xD;
      group, the schwannomas that will be stable and a small group where the schwannomas will&#xD;
      decrease.&#xD;
&#xD;
      The secondary purpose is that the investigators want to know the threshold values: a minimum&#xD;
      volume under which we are sure that the schwannoma will not increase, a maximum value where&#xD;
      it will increase and if its evolution can be correlated to clinical or radiological criteria.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA</measure>
    <time_frame>1 hour after the realization of the MRI</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Schwannoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients having a typical vestibular schwannoma diagnosis during the first MRI, having a&#xD;
        minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General&#xD;
        Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  having a typical vestibular schwannoma diagnosis during the first MRI, having a&#xD;
             minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General&#xD;
             Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg&#xD;
&#xD;
          -  patients consenting to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intra-labyrinthical extension&#xD;
&#xD;
          -  treatment before the 3 MRIs&#xD;
&#xD;
          -  no injection of gadolinium&#xD;
&#xD;
          -  atypical diagnosis&#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_contact>
    <last_name>Aïna VENKATASAMY, MD</last_name>
    <phone>33 3 88 12 78 65</phone>
    <email>aina.venkatasamy@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Saïd CHAYER, PhD, HDR</last_name>
    <phone>33 3 88 11 66 90</phone>
    <email>said.chayer@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service Imagerie 1</name>
      <address>
        <city>Srtrasbourg</city>
        <state>Strasbourg</state>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aïna VENKATASAMY, MD</last_name>
      <phone>33 3 88 12 78 65</phone>
      <email>aina.venkatasamy@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>Aïna VENKATASAMY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francis VEILLON, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julien UTTNER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schwannoma</keyword>
  <keyword>cochleovestibular schwannomas</keyword>
  <keyword>cochleovestibular</keyword>
  <keyword>intra labyrinthine schwannoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurilemmoma</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/NCT04417868
org study id: 7560
nct id: NCT04417868
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators want to know the natural history of the vestibular schwannomas: increasing,
      decreasing or stability, by monitoring more than 3 MRIs during a span of more than 2 years.
      They will obtain 3 groups: the volume increasing schwannomas which will be the most important
      group, the schwannomas that will be stable and a small group where the schwannomas will
      decrease.

      The secondary purpose is that the investigators want to know the threshold values: a minimum
      volume under which we are sure that the schwannoma will not increase, a maximum value where
      it will increase and if its evolution can be correlated to clinical or radiological criteria.
observational model: Cohort
time perspective: Retrospective
measure: Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA
time frame: 1 hour after the realization of the MRI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aïna VENKATASAMY, MD
phone: 33 3 88 12 78 65
email: aina.venkatasamy@chru-strasbourg.fr
last name: Saïd CHAYER, PhD, HDR
phone: 33 3 88 11 66 90
email: said.chayer@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Neurilemmoma