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CompletedNCT06827106Updated Feb 14, 2025

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

An observational study in Normal CT Scan, Dysplasic Disease and Tumoral Disease, sponsored by Aix Marseille Université. Completed at 1 site in France. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Aix Marseille Université · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
60
Ages
13 Years and older
Sex
All
01

Study 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.

Read the detailed description

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. The spatial resolution of conventional high-resolution CT is 0.5mm, whereas the dimensions of the smallest structure in the middle ear, the stapes, are of the order of 0.19mm). Despite their small size, pathological changes to these structures can have major consequences for hearing and balance, and may require exploratory or reconstructive surgery.

On the other hand, limiting patient exposure to ionizing radiation is a growing concern for the medical world, patients and public authorities alike. In the literature, effective doses vary from 50 to 970 µSv, and most protocols expose the crystalline lens (direct exposure), varying from 10 to 40 mGy in helical acquisition, depending on the technical protocol.

The International Commission on Radiological Protection has therefore proposed that the "As Low As Reasonably Achievable Radiation Exposure" (ALARA) principle should be followed, i.e. maintaining optimum spatial resolution, particularly for key anatomical landmarks in rock imaging, while reducing noise levels and radiation dose.

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.

To the best of our knowledge, no Diagnostic Reference Level has yet been established in the literature.

The idea would therefore be to determine objective quality criteria, based on key, clinically relevant anatomical structures, evaluated in several French centers, as part of a standard offer of care, in order to seek the right balance between the dose delivered to the patient and the quality of the image required, and thus provide clinicians with precise, reproducible tools for imaging the rock, for diagnostic or interventional purposes.

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. This is a retrospective data collection, carried out between 2023 and 2024, including 60 patients who underwent a CT scan of the temporal bone in a hospital center in mainland France, during their course of care.

Image quality was assessed independently, in a blinded fashion, by two radiologists and two ENT physicians, on the basis of a 5-point Likert semi-quantitative visual scale.

To calculate radiation exposure, the dose volume index (CTDIvol) was retrieved from the dose report for each patient, and the length-dose product (LDP) was provided automatically by the various consoles.

02

Conditions studied

  • 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
03

In context

Communicable Diseases

4,447 studies on the registry are indexed under Communicable Diseases; 514 are open to participants now.

This study's enrollment of 60 is below the median of 240 across 1,501 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Aix Marseille Université is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Normal anatomy of the inner and middle ear

Exclusion criteria

Exclusion Criteria:

  • Motion artifacts
  • Dysplastic pathologies
  • Tumoral pathologies
  • Infectious pathologies
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. to determine temporal bone image quality criteria

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

    Time frame: 21 months

Secondary outcomes

  1. to reduce the radiation dose delivered to patients

    To compare the radiation dose received by each patient in Sievert (Sv)

    Time frame: 21 months

07

Study locations

1 site
  • Aix Marseille University
    Marseille, PACA 13000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2023 to primary completion in Nov 2024, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2025
First posted
Feb 14, 2025
StartActual
Feb 14, 2023
Primary completionActual
Nov 22, 2024
CompletionActual
Jan 15, 2025
Last update
Feb 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06827106
Lead sponsor
Aix Marseille Université
Responsible party
IFTISSEN FRANCOIS (Médical Resident, Aix Marseille Université) — Principal investigator
First posted
Feb 14, 2025
Start date
Feb 14, 2023
Primary completion
Nov 22, 2024
Completion
Jan 15, 2025
Last update
Feb 14, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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