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
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.
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.
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 →Aix Marseille Université is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Patients with an indication for a CT scan of the temporal bone in a hospital in mainland France
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Exclusion Criteria:
to determine temporal bone image quality criteria
Qualitative comparison of 17 anatomical structures according to a 5-level Likert scale
Time frame: 21 months
to reduce the radiation dose delivered to patients
To compare the radiation dose received by each patient in Sievert (Sv)
Time frame: 21 months
Plan to share: No
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Ran from Feb 2023 to primary completion in Nov 2024, 21 months.
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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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Aix Marseille Université