Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging

NCT ID: NCT03305796

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholesteatoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diffusion magnetic resonance imaging

Patients with suspected cholesteatoma will have diffusion magnetic resonance imaging

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amer Ragab Ahmed

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

amer ragab, resident

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ahmed Abdel-Aleem, professor

Role: CONTACT

Phone: 01222892745

Email: [email protected]

Mohamed Modather, lecturer

Role: CONTACT

Phone: 01061577266

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9673317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20860924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10444978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10997063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10478595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11528272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11688697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23892691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12595101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17768611 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cholesteatoma

Identifier Type: -

Identifier Source: org_study_id