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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05533840
Enrollment
1500
Registered
2022-09-09
Start date
2022-09-30
Completion date
2024-12-31
Last updated
2022-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Tinnitus, Vertigo

Keywords

Otology, Medical imaging, Tomography, X-ray, Diagnosis, Resolution

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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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

Interventions

DIAGNOSTIC_TESTultra-high-resolution computed tomography exams

Participants in the age groups undergo ultra-high-resolution computed tomography exam

Sponsors

Beijing Tongren Hospital
CollaboratorOTHER
Beijing Obstetrics and Gynecology Hospital
CollaboratorOTHER
Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Subjective and objective evaluation methods for CT image quality2022.1-2024.12Image 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 CT2022.1-2024.12diameters in milimeter
Quantitative diagnostic standard for ear diseases based on U-HRCT image2022.1-2024.12shape and position of conductive and senserineural hearing pathways

Countries

China

Contacts

Primary ContactPengfei Zhao, Prof.
zhaopengf05@163.com+8613811048563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026