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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05966363
Acronym
ICSI
Enrollment
35
Registered
2023-07-28
Start date
2023-07-26
Completion date
2024-09-19
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irradiation; Adverse Effect

Keywords

irradiation, TDM, Cone Beam, CT, CBCT

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).

Interventions

RADIATIONNanodot

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

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CT and CBCT induced Irradiation in ear imaging in adults with adult protocol9 monthTo 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

MeasureTime frameDescription
CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol9 monthTo 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 protocol9 monthTo compare CT and CBCT induced irradiation in ear imaging in adults and children \> 15 years of age who have benefited from a pediatric protocol.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026