Clinical trial NCT03974256: Preparation of Radiopharmaceuticals by Automaton: Operators Dosimetry
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exposure, Radiation
Keywords: Automaton
Dosimetry
Radiopharmaceutical
Technetium-99m
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Interventional study, multicenter, randomized, cross-over, open, at risk and minimal constraints
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total radiopharmaceutical activity prepared in mega-becquerel (MBq)
timeFrame: Throughout 4 working days of each methods
measure: Number of days of handling
timeFrame: Throughout 4 working days of each methods
Secondary outcomes:
measure: 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
timeFrame: Throughout 4 working days of each methods
measure: 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")
timeFrame: After 4 working days of this method
measure: 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")
timeFrame: After 4 working days of each methods
measure: 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)
timeFrame: Throughout 4 working days of each methods
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy - Brabois
Study officials:
affiliation: GIE NANCYCLOTEP
name: Rachel GRIGNON, Technologist
role: PRINCIPAL_INVESTIGATOR
References: