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临床试验/NCT01436006
NCT01436006已完成不适用

Adult and Paediatric Patient Radiation Doses From Multidetector CT Scans: a National Survey

University of Palermo1 个研究点 分布在 1 个国家目标入组 6,700 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,700
试验地点
1
主要终点
Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Abdomen CT Examinations.

研究概览

简要总结

The situation in Italy regarding radiation dose to patients undergoing Multidetector row Computed Tomography (MDCT) scans is unclear despite Italian law require that each centre check the Reference Dose Level (RDL) every two years. RDL in CT were first suggested in a document of 1998 published by the European Commission (EUR16262/1998) based on the results of an older survey in the UK from the late 1980s. Those RDLs, expressed in terms of Computed Tomography Dose Index (CTDI) and Dose Length Product (DLP), are reported in the Italian law (D.Lgs.187/00). However, in Italy there is no governmental authority comparable to the UK's National Radiological Protection Board, deputed to dose evaluation and protection.

An overview of the Italian situation is relevant in order to know the actual dose levels for MDCT administered to patients both adults and paediatrics.

详细描述

CT imaging is rapidly growing and now represents an indispensable medical procedure for many clinical conditions. The widespread availability and expanding use of multidetector CT (MSCT) due to its high performance and very short acquisition times, has resulted in an increase in both frequency of procedures and level of patient exposures from CT scan examinations, but issues related to radiation, including potential risks, have been relatively neglected. Particular attention should be given to CT scans in children, as they represent about 10% of all the X-ray studies performed on them, accounting for about 75% of the total dose administered. CT in children should be performed only when absolutely necessary as their longer life expectation and sensitivity to X-ray radiations may increase the risk of causing radiation-induced neoplasm's in later years.

According to the 2000 report of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) the frequency of CT examinations in countries with high healthcare levels has increased by a factor of 8; with the mean effective dose increasing from 1,3 mSv in the 1970s to 8,8 mSv per year per 1000 persons in the early 1990s. In Switzerland, Germany and United Kingdom the increases in the number of reported CT examinations ranged between 39% and 70% over just the period 1998-2002. The 2000 ISTAT report's estimated that 1479 CT apparatus were installed in Italy performing a total of 3.327.750 CT examinations [3]. Considering an increase of 40% every 5 years, comparable to other European countries, 6.000.000 CT examinations can be estimated for 2010.

The primary objective of the study is to obtain a snapshot of Italian CT practice in adults and children that is up-to-date in regards to information concerning multidetector 16- and 64- row CT. A second goal is to update the national reference dose levels.

The study should further establish a sustainable database for the ongoing collation of further data from local surveys of CT. This will facilitate the analysis of trends and periodic review of national reference doses for CT in a way similar to other European countries.

Radiology departments dealing with adult and paediatric CT in Italy will receive an invitation to participate to the survey and a questionnaire regarding some important features of their CT equipment. Four common protocols will be used for dose calculation: CT scan of the head, lumbar spine, chest and abdomen. Cardiac CT data will be collected only for adults, as in children other examinations, such as MR are commonly preferred to CT just for radioprotection reasons.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients that will be submitted to "standard" protocols for CT of the: head, chest, abdomen, lumbar spine and cardiac

排除标准

  • Non standard MDCT examination

结局指标

主要结局

Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Abdomen CT Examinations.

时间窗: one year

Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest Abdomen and Pelvis CT Examinations.

时间窗: one year

Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Cardiac CT Examinations.

时间窗: one year

Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest CT Examinations.

时间窗: one year

Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Head CT Examinations.

时间窗: One year

Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Spine CT Examinations.

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergio Salerno

Associate Professor

University of Palermo

研究点 (1)

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