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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533840
• Other study ID #: 2022-1-1111
• Status: Recruiting
• Start date: September 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: Beijing Friendship Hospital
• Contact: Pengfei Zhao, Prof.
• Phone: +8613811048563
• Email: zhaopengf05[@]163.com
• Is FDA regulated: No
• Study type: Observational

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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Tinnitus
• Vertigo

Intervention

Diagnostic Test:
• ultra-high-resolution computed tomography exams
Participants in the age groups undergo ultra-high-resolution computed tomography exam

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Obstetrics and Gynecology Hospital, Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective and objective evaluation methods for CT image quality	Image quality (Likert score) and image noise will be combined to report the optimal image quality-noise combination	2022.1-2024.12
Primary	Radiological anatomy of normal ears based on ultra-high resolution CT	diameters in milimeter	2022.1-2024.12
Primary	Radiological anatomy of normal ears based on ultra-high resolution CT	angle in degree	2022.1-2024.12
Primary	Quantitative diagnostic standard for ear diseases based on U-HRCT image	shape and position of conductive and senserineural hearing pathways	2022.1-2024.12
Primary	Quantitative diagnostic standard for ear diseases based on U-HRCT image	size in milimeter of conductive and senserineural hearing pathways	2022.1-2024.12