Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging

Cholesteatoma Clinical Trial

Official title:

Detection of Cholesteatoma Using Diffusion Magnetic Resonance Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03305796
• Other study ID #: Cholesteatoma
• Status: Not yet recruiting
• Phase: N/A
• First received: October 5, 2017
• Last updated: October 5, 2017
• Start date: November 2017
• Est. completion date: February 2019

Study information

• Verified date: October 2017
• Source: Assiut University
• Contact: ahmed Abdel-Aleem, professor
• Phone: 01222892745
• Email: abduleen[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Cholesteatoma

Intervention

Radiation:
• Diffusion magnetic resonance imaging
Patients with suspected cholesteatoma will have diffusion magnetic resonance imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. Review. — View 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. Review. — View Citation

Bammer R. Basic principles of diffusion-weighted imaging. Eur J Radiol. 2003 Mar;45(3):169-84. Review. — View Citation

Bergui M, Zhong J, Bradac GB, Sales S. Diffusion-weighted images of intracranial cyst-like lesions. Neuroradiology. 2001 Oct;43(10):824-9. — View 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. — View 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. Epub 2007 Sep 3. — View 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. — View Citation

Nevoux J, Lenoir M, Roger G, Denoyelle F, Ducou Le Pointe H, Garabédian 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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