Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis (CONBEAM OTO)

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

Study Overview

• Status: Terminated
• Conditions: Otosclerosis
• Intervention / Treatment: Device: Cone Beam CT

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cone Beam CT; Each patient will undergo a Cone Beam CT and a MDCT	Device: Cone Beam CT; Each patient will undergo a Cone Beam CT and a MDCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiologic grades of otosclerosis	Description of the radiologic grades of otosclerosis, based on Veillon's classification	1 day
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
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
radiation dosage	Comparison of radiation dosage between Cone Beam and MDCT	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2022
• Primary Completion (ACTUAL): August 1, 2022
• Study Completion (ACTUAL): August 1, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (ACTUAL): January 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Otosclerosis; Conductive hearing loss; Cone Beam
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otosclerosis
• Other Study ID Numbers: CHUBX 2021/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No