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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05966363

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Irradiation; Adverse Effect	Radiation: Nanodot

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	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.

Arm

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT05966363

Other Study ID Numbers:

2023/738

First Posted:

Jul 28, 2023

Last Update Posted:

Jul 28, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

Study Results

No Results Posted as of Jul 28, 2023