<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/NCT04489550</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0224</org_study_id>
    <nct_id>NCT04489550</nct_id>
  </id_info>
  <brief_title>How Long Must the MRI Follow-up Last to Safely Identify Middle Ear Residual Cholesteatoma</brief_title>
  <official_title>Optimal Duration of Magnetic Resonance Imaging (MRI) Follow-up to Safely Identify Middle Ear Residual Cholesteatoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted&#xD;
      magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are&#xD;
      available regarding a suitable length of imaging follow-up. The present study aimed to&#xD;
      determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A retrospective, monocentric study was performed between 2013 and 2019 and included all&#xD;
      patients regularly followed-up after canal wall-up tympanoplasty with at least two non-EP DWI&#xD;
      performed on the same 1.5T MRI scanner. MR images were reviewed independently by two&#xD;
      radiologists. Sensitivity and specificity values were calculated as a function of time after&#xD;
      the surgery. Receiver operating characteristics (ROC) curves were analyzed to determine the&#xD;
      optimal follow-up duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>MRI sensitivity and specificity values as a function of the duration of the follow-up</measure>
    <time_frame>1 day</time_frame>
    <description>MRI sensitivity and specificity values as a function of the duration of the follow-up. Since no official recommendations are available in the literature, the decision regarding the number of MRIs and the time lapse between any two was left to the discretion of the surgeon</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Receiver operating characteristics (ROC) curves</measure>
    <time_frame>1 day</time_frame>
    <description>the receiver operating characteristics (ROC) curves</description>
  </secondary_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Middle Ear Cholesteatoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with history of middle-ear cholesteatoma, who underwent canal wall-up&#xD;
        tympanoplasty and are therefore at risk of residual cholesteatoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - patients regularly followed-up for middle ear cholesteatoma, who underwent two or more&#xD;
        non-EP DWI performed on the same 1.5 Tesla MRI scanner&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - congenital cholesteatomas, tympanoplasty with canal wall-down technique, or suspicion of&#xD;
        residual cholesteatoma on the first MRI follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederic Venail, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>residual cholesteatoma</keyword>
  <keyword>imaging follow-up</keyword>
  <keyword>canal wall-up tympanoplasty</keyword>
  <keyword>non-EP DWI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholesteatoma, Middle Ear</mesh_term>
    <mesh_term>Cholesteatoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04489550
org study id: RECHMPL20_0224
nct id: NCT04489550
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted
      magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are
      available regarding a suitable length of imaging follow-up. The present study aimed to
      determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma
A retrospective, monocentric study was performed between 2013 and 2019 and included all
      patients regularly followed-up after canal wall-up tympanoplasty with at least two non-EP DWI
      performed on the same 1.5T MRI scanner. MR images were reviewed independently by two
      radiologists. Sensitivity and specificity values were calculated as a function of time after
      the surgery. Receiver operating characteristics (ROC) curves were analyzed to determine the
      optimal follow-up duration.
observational model: Cohort
time perspective: Retrospective
measure: MRI sensitivity and specificity values as a function of the duration of the follow-up
time frame: 1 day
description: MRI sensitivity and specificity values as a function of the duration of the follow-up. Since no official recommendations are available in the literature, the decision regarding the number of MRIs and the time lapse between any two was left to the discretion of the surgeon
measure: Receiver operating characteristics (ROC) curves
time frame: 1 day
description: the receiver operating characteristics (ROC) curves
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Frederic Venail, MD, PhD
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Cholesteatoma, Middle Ear
mesh term: Cholesteatoma
sharing ipd: Undecided
ipd description: NC