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

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Irradiation; Adverse Effect

Treatments

Radiation: Nanodot

Study type

Observational

Funder types

Other

Identifiers

NCT05966363
2023/738

Details and patient eligibility

About

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).

Enrollment

35 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

35 participants in 2 patient groups

CBCT
Description:
Patients receiving a Cone Beam of the rocks as part of a cochlear implant position check at Besançon University Hospital
Treatment:
Radiation: Nanodot
CT
Description:
Patients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined
Treatment:
Radiation: Nanodot

Trial contacts and locations

1

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Central trial contact

Astrid POZET, Msc; Anne-Line MUTSCHLER, MD

Data sourced from clinicaltrials.gov

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