Preparation of Radiopharmaceuticals by Automaton: Operators Dosimetry (AUTOTEC)
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|ClinicalTrials.gov Identifier: NCT03974256|
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Exposure, Radiation||Other: Training in the use of the automaton||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Interventional study, multicenter, randomized, cross-over, open, at risk and minimal constraints|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
No Intervention: Group standard method
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
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
2 days training on automaton use
- Total radiopharmaceutical activity prepared in mega-becquerel (MBq) [ Time Frame: Throughout 4 working days of each methods ]For each of the two methods of preparation
- Number of days of handling [ Time Frame: Throughout 4 working days of each methods ]For each of the two methods of preparation
- 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 [ Time Frame: Throughout 4 working days of each methods ]For each of the two methods of preparation
- 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") [ Time Frame: After 4 working days of this method ]During the automated method of preparation
- 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") [ Time Frame: After 4 working days of each methods ]During the automated method of preparation
- 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) [ Time Frame: Throughout 4 working days of each methods ]For each of the two methods of preparations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974256
|Contact: Rachel GRIGNON, Technologist||+33 email@example.com|
|Contact: Véronique ROCH, MSc||+33 firstname.lastname@example.org|
|CHRU Nancy - Brabois||Not yet recruiting|
|Vandoeuvre-les-Nancy, France, 54511|
|Contact: Rachel GRIGNON +33 383155423 email@example.com|
|Contact: Véronique ROCH +33 383154276 firstname.lastname@example.org|
|Principal Investigator:||Rachel GRIGNON, Technologist||GIE NANCYCLOTEP|