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临床试验/NCT02532127
NCT02532127已完成不适用

Dentomaxillofacial Paediatric Imaging: An Investigation Towards Low Dose Radiation Induced Risks

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 50 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Identify and develop biomarkers for radiation-induced health effects

研究概览

简要总结

Cone Beam Computed Tomography (CBCT) is an emerging X-ray technology that has found wide applications in dentomaxillofacial imaging. The ability to provide high-resolution 3D images has resulted in a significant increase in the volume of dental radiology procedures. Although CBCT is associated with higher radiation risk to the patient than conventional dental X-ray imaging (intraoral or panoramic), it is considered to be 'low dose' imaging as defined by the High Level Expert Group (HLEG) with doses ranging from a few microsieverts (μSv) to millisieverts (mSv) per examination.

This proposal is set to tackle important issues raised by the HLEG and the Multidisciplinary European Low Dose Initiative (MELODI) platform. In particular, as deduced by the name DIMITRA (Dentomaxillofacial paediatric imaging: an investigation towards low dose radiation induced risks), the project focuses on the uncertainties associated with radiation-induced health risks at low doses in paediatric dentistry and is a multidisciplinary effort to approach the involved risks from different yet interrelated perspectives: radiobiological characterisation, dosimetric quantification, epidemiological surveying and image quality & dose optimization. A unique Monte Carlo simulation (MC) framework will be used to accurately calculate organ doses in dental CBCT imaging, to quantify the radiation induced risk and to feed the radiobiology team with the appropriate data towards the identification, development and validation of biomarkers for radiation induced health effects. Furthermore, it will constitute the basis upon setting up a gender and age related epidemiology study. The balance between image quality and dose levels will be explored aiming at reducing the risk through image quality optimization.

It is expected that DIMITRA's outcomes and deliverables can be presented to a wider forum via a dissemination meeting, leading to further recommendations and potential future adaptations for the use of CBCT in paediatric dentistry.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
— 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Prospective study with saliva sampling: Patients referred for a CBCT scan from their doctor
  • Retrospective study: recorded patients (age 0 - 22) referred to UZ Leuven in the last 2 years including cleft palate patients

排除标准

  • 未提供

结局指标

主要结局

Identify and develop biomarkers for radiation-induced health effects

时间窗: 24 hours after CBCT radiation

Saliva sampling

时间窗: 30 minutes before radiation

Patient-specific dosimetry

时间窗: dose retrospectively calculated for each patient up to 1 week after irradiation, patients will be followed until the end of the study (May 2017)

Using a Monte-Carlo based simulator, specifically designed for dental CBCT imaging, adjusted towards specific CBCT geometries and a series of realistic voxel models of paediatric patients will allow the assessment of variability in doses due to differences in anatomy between patients. The organ and effective doses are used for calculating the associated age and gender related cancer risks attributable to dental and maxillofacial CBCT scans.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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