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临床试验/NCT05966363
NCT05966363尚未招募不适用

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

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
CT and CBCT induced Irradiation in ear imaging in adults with adult protocol

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 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.

次要结局

  • CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol(9 month)
  • CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol(9 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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