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

NCT05966363 | Completed

• 1 other identifier: 2023/738
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Irradiation; Adverse Effect

Keywords

irradiation; TDM; Cone Beam; CT; CBCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol

  9 month

• CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol

  9 month

Study Arms (2)

CBCT

Patients receiving a Cone Beam of the rocks as part of a cochlear implant position check at Besançon University Hospital

Radiation: Nanodot

CT

Patients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined

Radiation: Nanodot

Interventions

Nanodot RADIATION

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

CBCT; CT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited during a consultation in the ENT department, either as part of a pre-cochlear implant assessment, or as part of a prescription for a CT scan of the petrous bone by the Besançon University Hospital ENT department department to be carried out at Besançon University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• Legal incapacity or limited legal capacity
• Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 28, 2023
• Study Start: July 26, 2023
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)