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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Irradiation; Adverse Effect
• Intervention / Treatment: Radiation: Nanodot

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Anne-Line MUTSCHLER, MD; Phone Number: +33381668238; Email: almutschler@chu-besancon.fr
• Study Contact Backup: Name: Astrid POZET, Msc; Phone Number: +33381218988; Email: apozet@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: CT; irradiation; CBCT; TDM; Cone Beam
• Other Study ID Numbers: 2023/738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No