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CompletedNCT05966363ICSIUpdated Sep 23, 2024

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

An observational study in Irradiation; Adverse Effect, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Sex
All
01

Study 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).

02

Conditions studied

  • Irradiation; Adverse Effect

Keywords

  • irradiation
  • TDM
  • Cone Beam
  • CT
  • CBCT
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

Exclusion criteria are :

  • Legal incapacity or limited legal capacity
  • Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No

Groups and cohorts

  • CBCT

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

    Radiation: Nanodot

  • CT

    Patients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined

    Radiation: Nanodot

Interventions

  • RadiationNanodot

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 month

Secondary outcomes

  1. 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.

    Time frame: 9 month

  2. 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.

    Time frame: 9 month

07

Study locations

1 site
  • CHU de Besançon
    Besançon, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05966363
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jul 28, 2023
Start date
Jul 26, 2023
Primary completion
Sep 19, 2024
Completion
Sep 19, 2024
Last update
Sep 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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