Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Quantitative diagnostic standard for ear diseases based on U-HRCT image
研究概览
简要总结
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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quantitative diagnostic standard for ear diseases based on U-HRCT image
时间窗: 2022.1-2024.12
size in milimeter of conductive and senserineural hearing pathways
Subjective and objective evaluation methods for CT image quality
时间窗: 2022.1-2024.12
Image quality (Likert score) and image noise will be combined to report the optimal image quality-noise combination
Radiological anatomy of normal ears based on ultra-high resolution CT
时间窗: 2022.1-2024.12
angle in degree
次要结局
未报告次要终点
研究者
Wang, Zhenchang
Vice President, Director of Medical Imaging Center
Beijing Friendship Hospital
