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

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Capital Medical University

Status

Enrolling

Conditions

Vertigo
Hearing Loss
Tinnitus

Treatments

Diagnostic Test: ultra-high-resolution computed tomography exams

Study type

Observational

Funder types

Other

Identifiers

NCT05533840
2022-1-1111

Details and patient eligibility

About

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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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

Enrollment

1,500 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,500 participants in 6 patient groups

Age under 18
Description:
Participants under the age of 18
Treatment:
Diagnostic Test: ultra-high-resolution computed tomography exams
Age 18-30
Description:
Participants aged 18-30
Treatment:
Diagnostic Test: ultra-high-resolution computed tomography exams
Age 31-40
Description:
Participants aged 31-40
Treatment:
Diagnostic Test: ultra-high-resolution computed tomography exams
Age 41-50
Description:
Participants aged 41-50
Treatment:
Diagnostic Test: ultra-high-resolution computed tomography exams
Age 51-60
Description:
Participants aged 51-60
Treatment:
Diagnostic Test: ultra-high-resolution computed tomography exams
Age ≥61
Description:
Participants aged ≥61
Treatment:
Diagnostic Test: ultra-high-resolution computed tomography exams

Trial contacts and locations

1

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Central trial contact

Pengfei Zhao, Prof.

Data sourced from clinicaltrials.gov

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