Clinical trial NCT05214053: Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis
Official title: Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Otosclerosis
Keywords: Otosclerosis
Cone Beam
Conductive hearing loss
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: False negative rate of Cone Beam for the diagnosis of otosclerosis
timeFrame: 1 day
Secondary outcomes:
measure: radiologic grades of otosclerosis
timeFrame: 1 day
measure: extension to round window
timeFrame: 1 day
measure: Existence of a bone canal around the labyrinthine portion of the facial nerve
timeFrame: 1 day
measure: radiation dosage
timeFrame: 1 day
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: