Evaluation of a New Strategy for the Preparation of Technetium Radioactive Medicaments Using an Innovative Automaton for Nuclear Medicine Examinations: Impact on the Dosimetry of Operators and on the Quality of Preparations
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Total radiopharmaceutical activity prepared in mega-becquerel (MBq)
研究概览
简要总结
The radiopharmaceuticals manipulation used in nuclear medicine department is a significant source of radiation for operators.
According to Article R. 4451-13 of the Labor Code, the exposure limit for hands and skin (average dose over a surface of 1 cm²) received during twelve consecutive months can't exceed the annual dose limit 500 millisieverts (mSv).
The radiopharmaceuticals manipulation exposes operators to the risk of exceeding this limit, as has been shown in a European study.
At present, there are automatons on the market but only for radiopharmaceutical fluorodeoxyglucose (FDG).
One of the advantages of such an automaton is to reduce irradiation of operators' hands during the radiopharmaceuticals preparation. This reduction can reach 95% according to certain authors and the type of automaton.
This study therefore proposes to evaluate the effect of an original, newly designed automaton on operators' dosimetry and the labelled radiopharmaceuticals' quality.
The hypothesis emitted in this study is that the use of this automaton would allow to reduce drastically operators' hands exposure and probably also to improve the precision of the prepared syringes.
This study will be done in a paired way, require a randomization in cross-over and each of the subjects included will be its own witness.
详细描述
Currently, radiopharmaceuticals for diagnostic purposes are prepared by operators, Technologist in Medical Electro-Radiology or/and Pharmacy Technicians, manually for radiopharmaceuticals labelled with Technetium-99m (99mTc), or using an automaton for radiopharmaceuticals FDG.
At present, there are automatons on the market but only for radiopharmaceuticals FDG.
However, these automatons are currently only used to split into individual doses radiopharmaceuticals FDG, the labelling radiopharmaceuticals being carried out before delivery in nuclear medicine departments.
The Sysark SAS's company has created and patented, with the collaboration of the Center of Research in Automatic Control of Nancy (CRAN, mixed unite of research 7039 common to the University of Lorraine and the CNRS) an innovative automaton for the preparation of radiopharmaceuticals labelled with 99mTc, used to perform scintigraphy examinations of nuclear medicine department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (age > 18 years)
- •Operators: Technologist in Electro-Radiology Medical / Pharmacy Technician
- •Operators experienced and autonomous in labelling radiopharmaceuticals with technetium-99m, at least one year
- •Operators having agreed to participate in the study, having received complete information on the organization of the research and having signed a free and informed consent
- •Operators affiliated to a social security scheme or beneficiary of such a scheme
排除标准
- •A woman of childbearing age who doesn't have effective contraception
- •Persons referred in Articles L. 1121-5, L 1121-8 of the French Public Health Code:
- •Pregnant woman, parturient or mother who is breastfeeding
- •Chil (not emancipated)
- •Adult subject to a measure of legal protection (guardianship, curators, safeguard of justice)
- •Adult unable to express consent
- •Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1
结局指标
主要结局
Total radiopharmaceutical activity prepared in mega-becquerel (MBq)
时间窗: Throughout 4 working days of each methods
For each of the two methods of preparation
Number of days of handling
时间窗: Throughout 4 working days of each methods
For each of the two methods of preparation
次要结局
- Accuracy in terms of activity (MBq) of prepared syringes, expressed as a percentage (%) of the prescribed target value, and compared between the automated device and the conventional manual method(Throughout 4 working days of each methods)
- A likert of 4 modalities will be used to evaluate the level of comfort in the automaton by operators (from "Very uncomfortable" to "Very comfortable")(After 4 working days of this method)
- A likert of 4 modalities will be used to evaluate the confidence level in the automaton by operators (from "Not at all confident" to "Totally confident")(After 4 working days of each methods)
- Level of operators' irradiation, measured by the breast dosimeter during the 4 days of preparation (in µSv) and expressed in relation to the total radiopharmaceuticals' activity prepared during the same period (in MBq)(Throughout 4 working days of each methods)