Skip to main content
OpenTrials
Completed

NCT Number: NCT05966363

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irradiation; Adverse Effect

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besançon

Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nanodot

Radiation

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

Primary outcomes

  1. CT and CBCT induced Irradiation in ear imaging in adults with adult protocol

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: ICSI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2023
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.