Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT

Study Overview
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Brief Summary
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Tinnitus, hearing loss and vertigo are the three major diseases of otology, affecting hundreds of millions of people in our country, and are major health problems. Ear structures and lesions are deeply embedded in the bone, and CT is the preferred examination technique. The key structures of the ear are small and the lesions are hidden. Spiral CT is not visible and undiagnosed due to insufficient spatial resolution. The ultra-high-resolution CT independently developed by our team has a spatial resolution of 50 μm, which is 6 times higher than that of high-end spiral CT, and solves the problem of not showing ear diseases. However, with the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable. It is urgent to carry out systematic research to create matching imaging plans, imaging anatomy standards and disease assessment standards to solve the problem of undiagnosed. problem. This project plans to build an adult and pediatric imaging solution based on ultra-high-resolution CT to optimize image quality and radiation dose; comprehensively evaluate conduction, sensory, and surgical-related fine structures of the ear, and establish a new 0.1mm-scale image anatomy atlas; A prospective study conducted by the center analyzes the hidden pathological changes of tinnitus, deafness and vertigo, evaluates the diagnostic efficacy of ultra-high-resolution CT for the above diseases, and establishes new diagnostic criteria for lesion detection, symptom correlation, and efficacy evaluation. This project will bring new changes to the practice of otology clinical diagnosis and treatment

Official Title
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Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT

Conditions
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Hearing Loss, Tinnitus, Vertigo

Intervention / Treatment
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* Diagnostic Test: ultra-high-resolution computed tomography exams


Participation Criteria
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Eligibility Criteria
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For healthy volunteers Inclusion Criteria: Meet the ethical requirements of U-HRCT examination Can cooperate to complete U-HRCT examination There is no relevant medical history in the side ear scanned Exclusion Criteria: Clinical symptoms related to middle and inner ear lesions, such as conduction deafness, sensorineural hearing loss, mixed deafness, vertigo, etc. Congenital inner ear malformation Diseases causing bone changes around the middle and inner ear, such as otitis media, tumors , otosclerosis, fibrous dysplasia, etc. history of previous ear surgery and trauma CT image artifacts or incomplete scan coverage incomplete clinical data For patients with otological diseases Inclusion Criteria: Due to tinnitus/deafness/peripheral vertigo/peripheral facial paralysis in the ENT department of our hospital Meet the ethical requirements of U-HRCT examination Can cooperate with the completion of U-HRCT examination Surgery in the ENT department of our hospital At least one follow-up or re-examination after discharge Exclusion Criteria: History of previous ear surgery and trauma CT image artifacts or incomplete scanning coverage Incomplete clinical data
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Age under 18<br>Participants under the age of 18 | Diagnostic Test: ultra-high-resolution computed tomography exams<br>* Participants in the age groups undergo ultra-high-resolution computed tomography exam<br>|
| Age 18-30<br>Participants aged 18-30 | Diagnostic Test: ultra-high-resolution computed tomography exams<br>* Participants in the age groups undergo ultra-high-resolution computed tomography exam<br>|
| Age 31-40<br>Participants aged 31-40 | Diagnostic Test: ultra-high-resolution computed tomography exams<br>* Participants in the age groups undergo ultra-high-resolution computed tomography exam<br>|
| Age 41-50<br>Participants aged 41-50 | Diagnostic Test: ultra-high-resolution computed tomography exams<br>* Participants in the age groups undergo ultra-high-resolution computed tomography exam<br>|
| Age 51-60<br>Participants aged 51-60 | Diagnostic Test: ultra-high-resolution computed tomography exams<br>* Participants in the age groups undergo ultra-high-resolution computed tomography exam<br>|
| Age ≥61<br>Participants aged ≥61 | Diagnostic Test: ultra-high-resolution computed tomography exams<br>* Participants in the age groups undergo ultra-high-resolution computed tomography exam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective and objective evaluation methods for CT image quality | Image quality (Likert score) and image noise will be combined to report the optimal image quality-noise combination | 2022.1-2024.12 | 
| Radiological anatomy of normal ears based on ultra-high resolution CT | diameters in milimeter | 2022.1-2024.12 | 
| Radiological anatomy of normal ears based on ultra-high resolution CT | angle in degree | 2022.1-2024.12 | 
| Quantitative diagnostic standard for ear diseases based on U-HRCT image | shape and position of conductive and senserineural hearing pathways | 2022.1-2024.12 | 
| Quantitative diagnostic standard for ear diseases based on U-HRCT image | size in milimeter of conductive and senserineural hearing pathways | 2022.1-2024.12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otology, Medical imaging, Tomography, X-ray, Diagnosis, Resolution