Exposure, RadiationAUTOTECNCT03974256
Preparation of Radiopharmaceuticals by Automaton: Operators Dosimetry
A study testing Training in the use of the automaton in people with Exposure, Radiation, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exposure, Radiation
- What is being tested?
- Training in the use of the automaton
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
CHRU Nancy - Brabois
Vandœuvre-lès-Nancy, 54511
Rachel GRIGNON, +33 383155423, r.grignon@chru-nancy.fr
Véronique ROCH, +33 383154276, v.roch@chru-nancy.fr
About this study
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
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).
Read more
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.
Read the 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.
- Conditions
- Exposure, Radiation
- Being tested
- Training in the use of the automaton
- Keywords
- Automaton, Dosimetry, Radiopharmaceutical, Technetium-99m
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the use of the automatonOther
2 days training on automaton use
| Study group | Role | What they receive |
|---|---|---|
| Group standard method | No intervention | 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 | 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 Receives: Other: Training in the use of the automaton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radiopharmaceutical activity prepared in mega-becquerel (MBq)
For each of the two methods of preparation
Measured: Throughout 4 working days of each methods
Number of days of handling
For each of the two methods of preparation
Measured: Throughout 4 working days of each methods
Secondary outcomes (4)
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
For each of the two methods of preparation
Measured: Throughout 4 working days of each methods
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")
During the automated method of preparation
Measured: After 4 working days of this method
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")
During the automated method of preparation
Measured: After 4 working days of each methods
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)
For each of the two methods of preparations
Measured: Throughout 4 working days of each methods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure, RadiationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional study, multicenter, randomized, cross-over, open, at risk and minimal constraints
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel GRIGNON, Technologist, Principal investigator, GIE NANCYCLOTEP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974256
- Sponsor's protocol ID
- PHRIP2018/AUTOTEC-GRIGNON-AS
- Acronym
- AUTOTEC
- Status last verified
- Aug 2021
- First submitted
- 29 May 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03974256
- Acronym / sponsor ID
- AUTOTEC / PHRIP2018/AUTOTEC-GRIGNON-AS
- Conditions
- Exposure, Radiation
- Keywords
- Automaton, Dosimetry, Radiopharmaceutical, Technetium-99m
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional study, multicenter, randomized, cross-over, open, at risk and minimal constraints
| Arm | Type | Receives |
|---|---|---|
| Group standard method | No intervention | –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 | Other: Training in the use of the automatonOperators 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in the use of the automaton2 days training on automaton use | Other | Group automated method |
Primary outcome
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
Number of days of handling
Time frame: Throughout 4 working days of each methods
For each of the two methods of preparation
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel GRIGNON, Technologist principal investigator
GIE NANCYCLOTEP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the use of the automaton in people with Exposure, Radiation, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel GRIGNON, Technologist (+33 383155423, r.grignon@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radiopharmaceutical activity prepared in mega-becquerel (MBq) (time frame: Throughout 4 working days of each methods). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.