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AzTrials

Normal CT ScanNCT06827106

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

An observational study of Normal CT Scan and Dysplasic Disease, run by Aix Marseille Université at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 years and olderHealthy volunteers can take part
Conditions the study is for
Normal CT Scan, Dysplasic Disease, Tumoral Disease
How many people
60 participants
Where
1 siteFrance
Study dates
14 Feb 2023to 15 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • Normal anatomy of the inner and middle ear

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Aix Marseille University

    Marseille, PACA, 13000

Other trials in France

About this study

Official title: Diagnostic Imaging of Temporal Bone : Technical Aspects, Applications Current and Dose-Quality Study of Differents CT Systems in Current Care

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.

Read more

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.

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
Medical subject headings
Communicable Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to determine temporal bone image quality criteria

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

    Measured: 21 months

Secondary outcomes (1)
  1. to reduce the radiation dose delivered to patients

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

    Measured: 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start14 Feb 2023
  3. Primary completion22 Nov 2024
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827106
Sponsor's protocol ID
Aix Marseille University
Status last verified
Feb 2025
First submitted
9 Feb 2025
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Normal CT Scan and Dysplasic Disease, run by Aix Marseille Université at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to determine temporal bone image quality criteria (time frame: 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.

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