Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis (CONBEAM OTO)
Primary Purpose
Otosclerosis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cone Beam CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Otosclerosis focused on measuring Otosclerosis, Cone Beam, Conductive hearing loss
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cone Beam CT
Arm Description
Each patient will undergo a Cone Beam CT and a MDCT
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
radiologic grades of otosclerosis
Description of the radiologic grades of otosclerosis, based on Veillon's classification
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
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
radiation dosage
Comparison of radiation dosage between Cone Beam and MDCT
Full Information
NCT ID
NCT05214053
First Posted
December 1, 2021
Last Updated
October 20, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT05214053
Brief Title
Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis
Acronym
CONBEAM OTO
Official Title
Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
not enough patients
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otosclerosis
Keywords
Otosclerosis, Cone Beam, Conductive hearing loss
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cone Beam CT
Arm Type
Experimental
Arm Description
Each patient will undergo a Cone Beam CT and a MDCT
Intervention Type
Device
Intervention Name(s)
Cone Beam CT
Intervention Description
Each patient will undergo a Cone Beam CT and a MDCT
Primary Outcome Measure Information:
Title
False negative rate of Cone Beam for the diagnosis of otosclerosis
Description
False negative rate of Cone Beam for the diagnosis of otosclerosis, compared to MDCT (gold standard).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
radiologic grades of otosclerosis
Description
Description of the radiologic grades of otosclerosis, based on Veillon's classification
Time Frame
1 day
Title
extension to round window
Description
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
Time Frame
1 day
Title
Existence of a bone canal around the labyrinthine portion of the facial nerve
Description
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
Time Frame
1 day
Title
radiation dosage
Description
Comparison of radiation dosage between Cone Beam and MDCT
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis
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