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

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the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable.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

Study Overview

• Status: Recruiting
• Conditions: Vertigo; Hearing Loss; Tinnitus
• Intervention / Treatment: Diagnostic test: ultra-high-resolution computed tomography exams

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Pengfei Zhao, Prof.; Phone Number: +8613811048563; Email: zhaopengf05@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Age under 18; Participants under the age of 18	Diagnostic test: ultra-high-resolution computed tomography exams; Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age 18-30; Participants aged 18-30	Diagnostic test: ultra-high-resolution computed tomography exams; Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age 31-40; Participants aged 31-40	Diagnostic test: ultra-high-resolution computed tomography exams; Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age 41-50; Participants aged 41-50	Diagnostic test: ultra-high-resolution computed tomography exams; Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age 51-60; Participants aged 51-60	Diagnostic test: ultra-high-resolution computed tomography exams; Participants in the age groups undergo ultra-high-resolution computed tomography exam
Age ≥61; Participants aged ≥61	Diagnostic test: ultra-high-resolution computed tomography exams; Participants in the age groups undergo ultra-high-resolution computed tomography exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Radiological anatomy of normal ears based on ultra-high resolution CT	diameters in milimeter	2022.1-2024.12
Radiological anatomy of normal ears based on ultra-high resolution CT	angle in degree	2022.1-2024.12
Quantitative diagnostic standard for ear diseases based on U-HRCT image	shape and position of conductive and senserineural hearing pathways	2022.1-2024.12
Quantitative diagnostic standard for ear diseases based on U-HRCT image	size in milimeter of conductive and senserineural hearing pathways	2022.1-2024.12

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Beijing Tongren Hospital; Beijing Obstetrics and Gynecology Hospital
• Investigators: Principal Investigator: Zhenchang Wang, Prof., Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Diagnosis; Resolution; Medical imaging; Otology; Tomography, X-ray
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Hearing Disorders; Vertigo; Hearing Loss; Tinnitus
• Other Study ID Numbers: 2022-1-1111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The project team has not decided the ways to share the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No