Comparison of Cone Beam Irradiation Versus Multi-detector Scanner for Ear Imaging

Study Overview
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Brief Summary
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The primary objective of this study is to compare the irradiation between Cone Beam and CT of the petrous bone. The primary endpoint is the measurement of equivalent doses per organ of interest (eyes, ears, thyroid and external genitalia). The investigators have set up a prospective monocentric study. The investigators will measure irradiation of these different organs using nanodots placed on the patient during imaging. The results of these measurements will be compared between Cone Beam (performed in the Besançon University Hospital ENT department for cochlear implant position checks) and CT (all indications combined).

Official Title
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Comparison of Cone Beam Irradiation Versus Multi-detector Scanner for Ear Imaging

Conditions
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Irradiation; Adverse Effect

Intervention / Treatment
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* Radiation: Nanodot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult or child patients of any gender and any age, including the pediatric population, receiving a CT scan of the petrous bone performed at Besançon University Hospital and prescribed in the Besançon University Hospital ENT department, or receiving a CBCT as part of an intraoperative check of cochlear implant position. Women menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, using an effective contraceptive method (oral contraceptives, contraceptive injections, intra-uterine devices, double-barrier method, contraceptive patches). Subject's non-opposition to study participation Affiliation with a French social security scheme or beneficiary of such a scheme. Exclusion criteria are : Legal incapacity or limited legal capacity Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CBCT<br>Patients receiving a Cone Beam of the rocks as part of a cochlear implant position check at Besançon University Hospital | Radiation: Nanodot<br>* Radiation measurements using nanodots placed on the eyes, ears, neck and lower abdomen during an imaging examination.<br>|
| CT<br>Patients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined | Radiation: Nanodot<br>* Radiation measurements using nanodots placed on the eyes, ears, neck and lower abdomen during an imaging examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT and CBCT induced Irradiation in ear imaging in adults with adult protocol | To compare CT and CBCT induced irradiation in ear imaging in adults and children > 15 years of age who have benefited from an adult protocol. | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol | To compare CT and CBCT induced irradiation in ear imaging in children ≤ 15 years of age who have benefited from a pediatric protocol. | 9 month | 
| CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol | To compare CT and CBCT induced irradiation in ear imaging in adults and children > 15 years of age who have benefited from a pediatric protocol. | 9 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irradiation, TDM, Cone Beam, CT, CBCT