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临床试验/NCT03665181
NCT03665181已完成不适用

Crystalline Exposition During Pediatric Cranial CT Imaging

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Efficiency of a bismuth based ocular protection associated with eye's lens dose modulation technique

研究概览

简要总结

This study focuses on reduction of X-rays dose applied to eye's lens during cranial CT in children. Principal objective is to analyse the efficiency of ocular bismuth masks, which are associated with an eye's lens dose modulation

详细描述

Eye's lens radiosensitivity represents an important subject of investigation in radiology. Indeed, eye's lens is recognised as one of the most radiosensitive organs in human body.[1,2] Radiation induced cataracts represent a determining effect of ionising radiations and has been widely studied. "International Commission for Radiological Protection" has evaluated cataract appearance threshold at 15 Gy in 1977 ",[3] then at 8 Gy [4] and 5 Gy in 2007.[5] Finally, in 2011 new studies gave rise to a new limit of appearance of 0.5 Gy. Eye's lens radiosensitivity seems to have been underestimated for several years and so there is a significant improvement to be made in radioprotection in order to protect to the best of the investigator's ability both patient and manipulator. This was also confirmed by the Directive EURATOM 2013/59 (which is in the process of being transposed in French legislation)[6] that reduces legal limit dose delivered to eye's lens from 150mSv to20mSv, for categories A workers.

This study is performed on 4 sequential groups, of ten patients, whereby one control group without ocular protection added. Other groups benefit either from a bismuth ocular protection, from a dose modulation applied to the eye's lens, or from both techniques associated. For each group, experiment is then focused on dose received by the eye's lens (measured using TLD detectors) as well as on Image quality obtained. Currently, there is no recommendation regarding lens protection for patient who benefit of a head tomodensitometry. Some practices are already used routinely but without a critical analysis of a comparison of their respective benefits.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
5 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 5 and 16 yrs old
  • Indication of cerebral CT with or without contrast regardless to indication or exam specificity
  • Patients beneficiary or affiliated to health system security
  • Oral consent for data processing from the child and his/her representative of parental authority

排除标准

  • Children anxious or agitated
  • Sedated patients or patients under general anaesthesia
  • Impossibility to position the skull on the orbito-meatal plane (intubation for example)
  • Patients under legal protection

结局指标

主要结局

Efficiency of a bismuth based ocular protection associated with eye's lens dose modulation technique

时间窗: Baseline

quantification of the efficiency of a bismuth based ocular protection associated with eye's lens dose modulation technique during cranial CT of children. This will be measured by the average dose difference relative to the number of helices, kV and mAs delivered between groups 1 and 2

次要结局

  • Efficiency of a bismuth based ocular protection(Baseline)
  • Efficiency of eye's lens dose modification(Baseline)
  • Image quality(Baseline)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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