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

Not yet recruiting

• Conditions: Irradiation; Adverse Effect
• Interventions: Radiation: Nanodot

• Registration Number: NCT05966363
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study First Posted: 2023-07-28
• Last Update Posted: 2023-07-28
• Study Start: 2023-09-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CBCT	Nanodot	Patients receiving a Cone Beam of the rocks as part of a cochlear implant position check at Besançon University Hospital
CT	Nanodot	Patients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined

Primary Outcome Measures

Name	Time	Method
CT and CBCT induced Irradiation in ear imaging in adults with adult protocol	9 month	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.

Secondary Outcome Measures

Name	Time	Method
CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol	9 month	To compare CT and CBCT induced irradiation in ear imaging in children ≤ 15 years of age who have benefited from a pediatric protocol.
CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol	9 month	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.

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France