Preparation of Radiopharmaceuticals by Automaton: Operators Dosimetry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Exposure, Radiation

Intervention / Treatment
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* Other: Training in the use of the automaton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Interventional study, multicenter, randomized, cross-over, open, at risk and minimal constraints
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group standard method<br>Operators work during 4 days with thermoluminescent dosimeters (TLD), according to the conventional manual method of preparation of technetium-99m labelled radioactive medicinal products for diagnostic according with good preparation practices and the recommendations contained in the summary of characteristics | |
| Experimental: Group automated method<br>Operators work during 4 days with TLD, according to the automated method of preparation of technetium-99m labelled radioactive medicinal products for diagnostic according with good preparation practices and the recommendations contained in the summary of characteristics | Other: Training in the use of the automaton<br>* 2 days training on automaton use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radiopharmaceutical activity prepared in mega-becquerel (MBq) | For each of the two methods of preparation | Throughout 4 working days of each methods | 
| Number of days of handling | For each of the two methods of preparation | Throughout 4 working days of each methods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | For each of the two methods of preparation | 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) | During the automated method of preparation | 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) | During the automated method of preparation | 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) | For each of the two methods of preparations | Throughout 4 working days of each methods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automaton, Dosimetry, Radiopharmaceutical, Technetium-99m