NCT03305796

Brief Summary

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

October 5, 2017

Last Update Submit

October 5, 2017

Conditions

Cholesteatoma

Outcome Measures

Primary Outcomes (1)

  • Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging

    To detect the ability of Diffusion Magnetic Resonance Imaging in detection of cholesteatoma as compared by post operative data

    with in one year

Interventions

Diffusion magnetic resonance imagingRADIATION

Patients with suspected cholesteatoma will have diffusion magnetic resonance imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presented with suspected cholesteatoma in assiut university hospital

You may qualify if:

  • all patients presented with suspected primary cholesteatoma ,high risk retraction pockets ,Suspected recurrent or residual cholesteatoma after surgery .

You may not qualify if:

  • Contraindication to magnetic resonance imaging (e.g., pacemaker, metallic implant,cochlear implant Or claustrophobia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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: 9673317BACKGROUND

  • 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: 20860924BACKGROUND

  • 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: 10444978BACKGROUND

  • 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: 10997063BACKGROUND

  • 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: 10478595BACKGROUND

  • 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: 11528272BACKGROUND

  • 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: 11688697BACKGROUND

  • 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: 23892691BACKGROUND

  • 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: 12595101BACKGROUND

  • 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: 17768611BACKGROUND

MeSH Terms

Conditions

Cholesteatoma

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • amer ragab, resident

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed Abdel-Aleem, professor

CONTACT

01222892745abduleen@aun.edu.eg

Mohamed Modather, lecturer

CONTACT

01061577266m.aboshanif@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 10, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

October 10, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share