ClinicalTrials.gg
Status unknownNCT03305796Updated Oct 10, 2017

Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging

An observational study in Cholesteatoma, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2017-10-10.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Sex
All
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Study 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 .

Read the detailed description

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.

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Conditions studied

  • Cholesteatoma

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03

In context

Cholesteatoma

21 studies on the registry are indexed under Cholesteatoma; 5 are open to participants now.

This study's planned enrollment of 30 is below the median of 75 across 11 observational studies indexed under Cholesteatoma.

Browse Cholesteatoma studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients presented with suspected cholesteatoma in assiut university hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • to magnetic resonance imaging (e.g., pacemaker, metallic implant,cochlear implant Or claustrophobia).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • RadiationDiffusion magnetic resonance imaging

    Patients with suspected cholesteatoma will have diffusion magnetic resonance imaging

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What researchers measure

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

    Time frame: with in one year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 9673317 ↗
  • 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. PubMed 20860924 ↗
  • 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. PubMed 10444978 ↗
  • 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. PubMed 10997063 ↗
  • 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. PubMed 10478595 ↗
  • 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. PubMed 11528272 ↗
  • 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. PubMed 11688697 ↗
  • 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. PubMed 23892691 ↗
  • 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. PubMed 12595101 ↗
  • 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. PubMed 17768611 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2017; primary completion for Dec 2018, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2017
First posted
Oct 10, 2017
StartEst.
Nov 2017
Primary completionEst.
Dec 2018
CompletionEst.
Feb 2019
Last update
Oct 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03305796
Lead sponsor
Assiut University
Responsible party
Amer Ragab Ahmed (Principle Investigator, Assiut University) — Principal investigator
First posted
Oct 10, 2017
Start date
Nov 2017 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Feb 2019 (estimated)
Last update
Oct 10, 2017

Study contacts

ahmed Abdel-Aleem, professor
Contact
abduleen@aun.edu.eg
01222892745
Mohamed Modather, lecturer
Contact
m.aboshanif@aun.edu.eg
01061577266
amer ragab, resident
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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