Preparation of Radiopharmaceuticals by Automaton: Operators Dosimetry (AUTOTEC)

Central Hospital, Nancy, France

Status: Not yet enrolling

Conditions: Exposure, Radiation

Treatments: Other: Training in the use of the automaton

Study type: Interventional

Funder types: Other

Identifiers

NCT03974256

PHRIP2018/AUTOTEC-GRIGNON-AS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Group standard method

No Intervention group

Description:

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 automated method

Experimental group

Description:

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

Treatment:

Other: Training in the use of the automaton