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Preparation of Radiopharmaceuticals by Automaton: Operators Dosimetry

NCT03974256 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-08-05

No results posted yet for this study

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.

Conditions

  • Exposure, Radiation

Interventions

OTHER

Training in the use of the automaton

2 days training on automaton use

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Rachel GRIGNON, Technologist · GIE NANCYCLOTEP

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-01-01
Completion
2024-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03974256 on ClinicalTrials.gov