Dose-Quality Study in the Temporal Bone Computed Tomography in Routine Care

NCT06827106 | Completed DMC

• 1 other identifier: Aix Marseille University
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Because of the complexity of the structures studied, imaging the temporal bone requires compliance with a number of image quality criteria, in order to achieve optimum spatial resolution of the most clinically relevant anatomical landmarks. On the other hand, limiting patient exposure to ionizing radiation is a growing concern for the medical world. The challenge here is twofold: to meet a certain number of image quality criteria, in order to achieve optimum spatial resolution for the most clinically relevant anatomical landmarks, while aiming to reduce the radiation dose delivered to patients as much as possible. Despite its routine use, few studies have compared the various commercially available solutions in terms of image quality or dose delivered, in daily practice. The primary objective of our study is a qualitative comparison of 7 different types of CT scans on 17 anatomical structures, useful in clinical practice, taking into account the contrast-to-noise ratio (CNR). The secondary endpoint was a comparison of radiation levels.

Conditions

Normal CT Scan; Dysplasic Disease; Tumoral Disease; Infectious Disease

Keywords

Temporal Bone; High-resolution CT scan; Spatial Resolution; Contrast-to-Noise Ratio; Radiation Dose; Diagnostic Reference Level; Observational Study; Multicenter Study; Retrospective Study; Quality Criteria; Daily Practice

Outcome Measures

Primary Outcomes (1)

• to determine temporal bone image quality criteria

  Qualitative comparison of 17 anatomical structures according to a 5-level Likert scale

  21 months

Secondary Outcomes (1)

• to reduce the radiation dose delivered to patients

  21 months

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with an indication for a CT scan of the temporal bone in a hospital in mainland France

You may qualify if:

• Normal anatomy of the inner and middle ear

You may not qualify if:

• Motion artifacts
• Dysplastic pathologies
• Tumoral pathologies
• Infectious pathologies

Sponsors & Collaborators

• Aix Marseille Université: lead

Study Sites (1)

Aix Marseille University

Marseille, PACA, 13000, France

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médical Resident

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 14, 2025
• Study Start: February 14, 2023
• Primary Completion: November 22, 2024
• Study Completion: January 15, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)