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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
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Exposure, Radiation Other: Training in the use of the automaton Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Interventional study, multicenter, randomized, cross-over, open, at risk and minimal constraints
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. Number of days of handling [ Time Frame: Throughout 4 working days of each methods ]
    For each of the two methods of preparation


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Rachel GRIGNON, Technologist +33 383155423 r.grignon@chru-nancy.fr
Contact: Véronique ROCH, MSc +33 383154276 v.roch@chru-nancy.fr

Locations
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France
CHRU Nancy - Brabois Not yet recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Rachel GRIGNON    +33 383155423    r.grignon@chru-nancy.fr   
Contact: Véronique ROCH    +33 383154276    v.roch@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Rachel GRIGNON, Technologist GIE NANCYCLOTEP

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03974256     History of Changes
Other Study ID Numbers: PHRIP2018/AUTOTEC-GRIGNON-AS
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Automaton
Dosimetry
Radiopharmaceutical
Technetium-99m

Additional relevant MeSH terms:
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Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action