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

NCT ID: NCT05533840

Last Updated: 2022-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-12-31

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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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

Detailed Description

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Conditions

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Hearing Loss Tinnitus Vertigo

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Age under 18

Participants under the age of 18

ultra-high-resolution computed tomography exams

Intervention Type DIAGNOSTIC_TEST

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

Age 18-30

Participants aged 18-30

ultra-high-resolution computed tomography exams

Intervention Type DIAGNOSTIC_TEST

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

Age 31-40

Participants aged 31-40

ultra-high-resolution computed tomography exams

Intervention Type DIAGNOSTIC_TEST

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

Age 41-50

Participants aged 41-50

ultra-high-resolution computed tomography exams

Intervention Type DIAGNOSTIC_TEST

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

Age 51-60

Participants aged 51-60

ultra-high-resolution computed tomography exams

Intervention Type DIAGNOSTIC_TEST

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

Age ≥61

Participants aged ≥61

ultra-high-resolution computed tomography exams

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ultra-high-resolution computed tomography exams

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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


* 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

* 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


* History of previous ear surgery and trauma
* CT image artifacts or incomplete scanning coverage
* Incomplete clinical data
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang, Zhenchang

Vice President, Director of Medical Imaging Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhenchang Wang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pengfei Zhao, Prof.

Role: CONTACT

+8613811048563

Facility Contacts

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Zhenchang Wang

Role: primary

+86-13501163497

Other Identifiers

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2022-1-1111

Identifier Type: -

Identifier Source: org_study_id

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