Clinical trial NCT05533840: Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Official title: Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Tinnitus
Vertigo
Keywords: Otology
Medical imaging
Tomography, X-ray
Diagnosis
Resolution
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
name: Beijing Obstetrics and Gynecology Hospital
First posted: 2022-09-09
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 50 healthy volunteers (100 ears)
* otological patients 1450 cases (tinnitus\>634 ears, hearing loss\>634 ears, and vertigo\>181 ears)

Brief summary: 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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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


Eligibility criteria: 1. 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
2. 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

Primary outcomes:
measure: Subjective and objective evaluation methods for CT image quality
timeFrame: 2022.1-2024.12
measure: Radiological anatomy of normal ears based on ultra-high resolution CT
timeFrame: 2022.1-2024.12
measure: Radiological anatomy of normal ears based on ultra-high resolution CT
timeFrame: 2022.1-2024.12
measure: Quantitative diagnostic standard for ear diseases based on U-HRCT image
timeFrame: 2022.1-2024.12
measure: Quantitative diagnostic standard for ear diseases based on U-HRCT image
timeFrame: 2022.1-2024.12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhenchang Wang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: