Preparation of Radiopharmaceuticals by Automaton: Operators Dosimetry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-07-01

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.

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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.

Conditions

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Exposure, Radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Interventional study, multicenter, randomized, cross-over, open, at risk and minimal constraints

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Training in the use of the automaton

Intervention Type OTHER

2 days training on automaton use

Interventions

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Training in the use of the automaton

2 days training on automaton use

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes