Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis

Otosclerosis Clinical Trial

— CONBEAM OTO  

Official title:

Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05214053
• Other study ID #: CHUBX 2021/21
• Status: Terminated
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the Cone Beam and the multi-detector computed tomography for diagnosis and pre-operative evaluation of otosclerosis in patients addressed for conductive hearing loss with intact tympanic membrane. The study aims to show that the Cone Beam offers equivalent performances with lower radiation dosage in this indication

Description:

Otosclerosis is an inflammatory bone remodeling disorder of the otic capsule, characterized by spongiotic new bone formation, causing stamped ankylosis that can result in conductive hearing loss. Until now, the gold standard imaging technique for diagnosis and pre-operative evaluation of otosclerosis has been multi-detector computed tomography (MDCT). Cone Beam computed tomography is a relatively recent imaging modality. It is associated with a lower radiation dosage compared to MDCT, and a high spatial resolution that allows a more precise analysis of bone structures. During the last 15 years, its use has been increasingly common in odontology and craniofacial surgery. Several studies have already studied the utility of Cone Beam for temporal bone pathologies, including recent retrospective studies that showed satisfying diagnostic performances for otosclerosis. Up to now, very few prospective studies have compared those two imaging modalities for otosclerosis diagnosis and pre-operative evaluation.

Therefore, those two exams will be performed in patients addressed to the hospital for conductive hearing loss with intact tympanic membrane. Thus, the performance of Cone Beam will be compared to MDCT, regarding the positive diagnosis of otosclerosis, the analysis of anatomical structures of the temporal bone for pre-operative evaluation, and also the benefits in terms of irradiation. The MDCTs will include fewer slices than routine MDCTs and will be centered on the area of interest, in order to keep a total radiation dosage smaller or equivalent to routine care

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (18 years and older)

• Requiring radiological assessment for conductive hearing loss with intact tympanic membrane, confirmed by otoscopy and audiogram

• Signed informed consent

• Affiliated or beneficiary of health insurance

Exclusion Criteria:

• Absence of otosclerosis on the MDCT

• History of middle ear surgery

• Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control

• Patient under legal protection

Related Conditions & MeSH terms

• Otosclerosis

Intervention

Device:
• Cone Beam CT
Each patient will undergo a Cone Beam CT and a MDCT

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	False negative rate of Cone Beam for the diagnosis of otosclerosis	False negative rate of Cone Beam for the diagnosis of otosclerosis, compared to MDCT (gold standard).	1 day
Secondary	radiologic grades of otosclerosis	Description of the radiologic grades of otosclerosis, based on Veillon's classification	1 day
Secondary	extension to round window	The parameter that will be assessed is the presence/absence of a bony hypodensity located on the round window bony structure .; CT will be considered as gold standard. CBCT may be less or equally accurate to detect this small hypodensity area structure	1 day
Secondary	Existence of a bone canal around the labyrinthine portion of the facial nerve	The parameter that will be assessed is the presence /absence of a bony structure covering the VIIth nerve a the level of the oval window.; CT will be considered as gold standard. CBCT may be less or equally accurate to detect this very thin bony structure , or even better in case of better detection	1 day
Secondary	radiation dosage	Comparison of radiation dosage between Cone Beam and MDCT	1 day