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

Irradiation; Adverse Effect Clinical Trial

— ICSI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05966363
• Other study ID #: 2023/738
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Anne-Line MUTSCHLER, MD
• Phone: +33381668238
• Email: almutschler[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Irradiation; Adverse Effect

Intervention

Radiation:
• Nanodot
Radiation measurements using nanodots placed on the eyes, ears, neck and lower abdomen during an imaging examination.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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