<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/NCT03305796</url>
  </required_header>
  <id_info>
    <org_study_id>Cholesteatoma</org_study_id>
    <nct_id>NCT03305796</nct_id>
  </id_info>
  <brief_title>Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging</brief_title>
  <official_title>Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Cholesteatoma is a retraction pocket lined with squamous epithelium lined with keratin debris&#xD;
      occurring within pneumatized spaces of the temporal bone. Cholesteatomas have a propensity&#xD;
      for growth, bone destruction, and chronic infection.High-resolution computerized tomography&#xD;
      is the method of choice for imaging the middle ear .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with recurrent cholesteatoma, computerized tomography can show the extent of&#xD;
      cholesteatoma in relation to the ossicles and mastoid process,but computerized tomography has&#xD;
      a high negative predictive value if neither a soft-tissue mass nor bony destructions are&#xD;
      shown.However, if a soft-tissue mass in the middle ear is seen on computerized tomography,&#xD;
      diagnosis of the mass is not possible because cholesteatoma, mucoid secretion, granulation&#xD;
      tissue and cholesterol granuloma can not be differentiated from one another on computerized&#xD;
      tomography.&#xD;
&#xD;
      Standard magnetic resonance imaging shows tissues better than computerized&#xD;
      tomography,Therefore in patients with cholesteatoma, magnetic resonance imaging plays a&#xD;
      complementary role to computerized tomography in the diagnostic workup, Although computerized&#xD;
      tomography provides excellent Bony resolution for showing the anatomy, magnetic resonance&#xD;
      imaging provides specificity in characterizing soft-tissue abnormalities shown on&#xD;
      computerized tomography,How ever standard magnetic resonance imaging frequently fails to&#xD;
      allow differentiation of cholesteatoma from other soft tissues or mucoid secretions,&#xD;
      particularly in patients who had ear surgery.&#xD;
&#xD;
      Recent studies of diffusion weighted magnetic resonance imaging show that it is sensitive to&#xD;
      cholesteatoma tissue.Recent studies highlights the ability of diffusion weighted magnetic&#xD;
      resonance imaging in differentiating cholesteatoma from granulation tissue in patients who&#xD;
      have undergone mastoidectomy and also these imaging modalities help in the diagnosis of&#xD;
      residual cholesteatoma. Diffusion weighted magnetic resonance imaging play an important role&#xD;
      in diagnosis of retraction pockets .&#xD;
&#xD;
      Diffusion weighted magnetic resonance imaging is based on the principle of random microscopic&#xD;
      motion (Brownian motion) of water molecules.This &quot;diffusion&quot; of water molecules differs in&#xD;
      each biological tissue, For example water molecules in cholesteatoma are less mobile giving&#xD;
      rise to a hyper-intense signal, while in other tissues as granulation tissues, water&#xD;
      molecules are more mobile thus appear less intense on diffusion weighted magnetic resonance&#xD;
      imaging sequence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging</measure>
    <time_frame>with in one year</time_frame>
    <description>To detect the ability of Diffusion Magnetic Resonance Imaging in detection of cholesteatoma as compared by post operative data</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cholesteatoma</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Diffusion magnetic resonance imaging</intervention_name>
    <description>Patients with suspected cholesteatoma will have diffusion magnetic resonance imaging</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients presented with suspected cholesteatoma in assiut university hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • all patients presented with suspected primary cholesteatoma ,high risk retraction&#xD;
             pockets ,Suspected recurrent or residual cholesteatoma after surgery .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to magnetic resonance imaging (e.g., pacemaker, metallic&#xD;
             implant,cochlear implant Or claustrophobia).&#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>amer ragab, resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ahmed Abdel-Aleem, professor</last_name>
    <phone>01222892745</phone>
    <email>abduleen@aun.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Modather, lecturer</last_name>
    <phone>01061577266</phone>
    <email>m.aboshanif@aun.edu.eg</email>
  </overall_contact_backup>
  <reference>
    <citation>Alexander AE Jr, Caldemeyer KS, Rigby P. Clinical and surgical application of reformatted high-resolution CT of the temporal bone. Neuroimaging Clin N Am. 1998 Aug;8(3):631-50.</citation>
    <PMID>9673317</PMID>
  </reference>
  <reference>
    <citation>Nevoux J, Lenoir M, Roger G, Denoyelle F, Ducou Le Pointe H, Garabedian EN. Childhood cholesteatoma. Eur Ann Otorhinolaryngol Head Neck Dis. 2010 Sep;127(4):143-50. doi: 10.1016/j.anorl.2010.07.001. Epub 2010 Aug 11.</citation>
    <PMID>20860924</PMID>
  </reference>
  <reference>
    <citation>Thomassin JM, Braccini F. [Role of imaging and endoscopy in the follow up and management of cholesteatomas operated by closed technique]. Rev Laryngol Otol Rhinol (Bord). 1999;120(2):75-81. French.</citation>
    <PMID>10444978</PMID>
  </reference>
  <reference>
    <citation>Blaney SP, Tierney P, Oyarazabal M, Bowdler DA. CT scanning in &quot;second look&quot; combined approach tympanoplasty. Rev Laryngol Otol Rhinol (Bord). 2000;121(2):79-81.</citation>
    <PMID>10997063</PMID>
  </reference>
  <reference>
    <citation>Vanden Abeele D, Coen E, Parizel PM, Van de Heyning P. Can MRI replace a second look operation in cholesteatoma surgery? Acta Otolaryngol. 1999;119(5):555-61. doi: 10.1080/00016489950180784.</citation>
    <PMID>10478595</PMID>
  </reference>
  <reference>
    <citation>Kimitsuki T, Suda Y, Kawano H, Tono T, Komune S. Correlation between MRI findings and second-Look operation in cholesteatoma surgery. ORL J Otorhinolaryngol Relat Spec. 2001 Sep-Oct;63(5):291-3. doi: 10.1159/000055760.</citation>
    <PMID>11528272</PMID>
  </reference>
  <reference>
    <citation>Bergui M, Zhong J, Bradac GB, Sales S. Diffusion-weighted images of intracranial cyst-like lesions. Neuroradiology. 2001 Oct;43(10):824-9. doi: 10.1007/s002340100595.</citation>
    <PMID>11688697</PMID>
  </reference>
  <reference>
    <citation>Alzahrani M, Saliba I. Tympanic membrane retraction pocket staging: is it worthwhile? Eur Arch Otorhinolaryngol. 2014 Jun;271(6):1361-8. doi: 10.1007/s00405-013-2644-4. Epub 2013 Jul 27.</citation>
    <PMID>23892691</PMID>
  </reference>
  <reference>
    <citation>Bammer R. Basic principles of diffusion-weighted imaging. Eur J Radiol. 2003 Mar;45(3):169-84. doi: 10.1016/s0720-048x(02)00303-0.</citation>
    <PMID>12595101</PMID>
  </reference>
  <reference>
    <citation>De Foer B, Vercruysse JP, Bernaerts A, Maes J, Deckers F, Michiels J, Somers T, Pouillon M, Offeciers E, Casselman JW. The value of single-shot turbo spin-echo diffusion-weighted MR imaging in the detection of middle ear cholesteatoma. Neuroradiology. 2007 Oct;49(10):841-8. doi: 10.1007/s00234-007-0268-3. Epub 2007 Sep 3.</citation>
    <PMID>17768611</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Amer Ragab Ahmed</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholesteatoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03305796
org study id: Cholesteatoma
nct id: NCT03305796
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cholesteatoma is a retraction pocket lined with squamous epithelium lined with keratin debris
      occurring within pneumatized spaces of the temporal bone. Cholesteatomas have a propensity
      for growth, bone destruction, and chronic infection.High-resolution computerized tomography
      is the method of choice for imaging the middle ear .
In patients with recurrent cholesteatoma, computerized tomography can show the extent of
      cholesteatoma in relation to the ossicles and mastoid process,but computerized tomography has
      a high negative predictive value if neither a soft-tissue mass nor bony destructions are
      shown.However, if a soft-tissue mass in the middle ear is seen on computerized tomography,
      diagnosis of the mass is not possible because cholesteatoma, mucoid secretion, granulation
      tissue and cholesterol granuloma can not be differentiated from one another on computerized
      tomography.

      Standard magnetic resonance imaging shows tissues better than computerized
      tomography,Therefore in patients with cholesteatoma, magnetic resonance imaging plays a
      complementary role to computerized tomography in the diagnostic workup, Although computerized
      tomography provides excellent Bony resolution for showing the anatomy, magnetic resonance
      imaging provides specificity in characterizing soft-tissue abnormalities shown on
      computerized tomography,How ever standard magnetic resonance imaging frequently fails to
      allow differentiation of cholesteatoma from other soft tissues or mucoid secretions,
      particularly in patients who had ear surgery.

      Recent studies of diffusion weighted magnetic resonance imaging show that it is sensitive to
      cholesteatoma tissue.Recent studies highlights the ability of diffusion weighted magnetic
      resonance imaging in differentiating cholesteatoma from granulation tissue in patients who
      have undergone mastoidectomy and also these imaging modalities help in the diagnosis of
      residual cholesteatoma. Diffusion weighted magnetic resonance imaging play an important role
      in diagnosis of retraction pockets .

      Diffusion weighted magnetic resonance imaging is based on the principle of random microscopic
      motion (Brownian motion) of water molecules.This "diffusion" of water molecules differs in
      each biological tissue, For example water molecules in cholesteatoma are less mobile giving
      rise to a hyper-intense signal, while in other tissues as granulation tissues, water
      molecules are more mobile thus appear less intense on diffusion weighted magnetic resonance
      imaging sequence.
observational model: Case-Only
time perspective: Prospective
measure: Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging
time frame: with in one year
description: To detect the ability of Diffusion Magnetic Resonance Imaging in detection of cholesteatoma as compared by post operative data
intervention type: Radiation
intervention name: Diffusion magnetic resonance imaging
description: Patients with suspected cholesteatoma will have diffusion magnetic resonance imaging
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: amer ragab, resident
role: Principal Investigator
affiliation: Assiut University
last name: ahmed Abdel-Aleem, professor
phone: 01222892745
email: abduleen@aun.edu.eg
last name: Mohamed Modather, lecturer
phone: 01061577266
email: m.aboshanif@aun.edu.eg
citation: Alexander AE Jr, Caldemeyer KS, Rigby P. Clinical and surgical application of reformatted high-resolution CT of the temporal bone. Neuroimaging Clin N Am. 1998 Aug;8(3):631-50.
PMID: 9673317
citation: Nevoux J, Lenoir M, Roger G, Denoyelle F, Ducou Le Pointe H, Garabedian EN. Childhood cholesteatoma. Eur Ann Otorhinolaryngol Head Neck Dis. 2010 Sep;127(4):143-50. doi: 10.1016/j.anorl.2010.07.001. Epub 2010 Aug 11.
PMID: 20860924
citation: Thomassin JM, Braccini F. [Role of imaging and endoscopy in the follow up and management of cholesteatomas operated by closed technique]. Rev Laryngol Otol Rhinol (Bord). 1999;120(2):75-81. French.
PMID: 10444978
citation: Blaney SP, Tierney P, Oyarazabal M, Bowdler DA. CT scanning in "second look" combined approach tympanoplasty. Rev Laryngol Otol Rhinol (Bord). 2000;121(2):79-81.
PMID: 10997063
citation: Vanden Abeele D, Coen E, Parizel PM, Van de Heyning P. Can MRI replace a second look operation in cholesteatoma surgery? Acta Otolaryngol. 1999;119(5):555-61. doi: 10.1080/00016489950180784.
PMID: 10478595
citation: Kimitsuki T, Suda Y, Kawano H, Tono T, Komune S. Correlation between MRI findings and second-Look operation in cholesteatoma surgery. ORL J Otorhinolaryngol Relat Spec. 2001 Sep-Oct;63(5):291-3. doi: 10.1159/000055760.
PMID: 11528272
citation: Bergui M, Zhong J, Bradac GB, Sales S. Diffusion-weighted images of intracranial cyst-like lesions. Neuroradiology. 2001 Oct;43(10):824-9. doi: 10.1007/s002340100595.
PMID: 11688697
citation: Alzahrani M, Saliba I. Tympanic membrane retraction pocket staging: is it worthwhile? Eur Arch Otorhinolaryngol. 2014 Jun;271(6):1361-8. doi: 10.1007/s00405-013-2644-4. Epub 2013 Jul 27.
PMID: 23892691
citation: Bammer R. Basic principles of diffusion-weighted imaging. Eur J Radiol. 2003 Mar;45(3):169-84. doi: 10.1016/s0720-048x(02)00303-0.
PMID: 12595101
citation: De Foer B, Vercruysse JP, Bernaerts A, Maes J, Deckers F, Michiels J, Somers T, Pouillon M, Offeciers E, Casselman JW. The value of single-shot turbo spin-echo diffusion-weighted MR imaging in the detection of middle ear cholesteatoma. Neuroradiology. 2007 Oct;49(10):841-8. doi: 10.1007/s00234-007-0268-3. Epub 2007 Sep 3.
PMID: 17768611
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Amer Ragab Ahmed
investigator title: Principle Investigator
mesh term: Cholesteatoma
sharing ipd: No