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

NCT ID: NCT05966363

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-26

Study Completion Date

2024-09-19

Brief Summary

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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).

Detailed Description

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Conditions

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Irradiation; Adverse Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CBCT

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

Nanodot

Intervention Type RADIATION

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

Nanodot

Intervention Type RADIATION

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

Interventions

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Nanodot

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

Intervention Type RADIATION

Eligibility Criteria

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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

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Besançon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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2023/738

Identifier Type: -

Identifier Source: org_study_id

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