Last reviewed · How we verify
NCT03974256: AUTOTEC
Preparation of Radiopharmaceuticals by Automaton: Operators Dosimetry
NA trial testing Training in the use of the automaton in Exposure, Radiation in 22 participants. Status unknown.
1 January 2023
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 22 |
| Start date | 1 January 2022 |
| Primary completion | 1 January 2023 |
| Estimated completion | 1 July 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Training in the use of the automaton
Conditions studied
- Exposure, Radiation — all drugs for Exposure, Radiation →
Sponsor
Central Hospital, Nancy, France
Who can join
18 and older, any sex, with Exposure, Radiation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03974256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
- NCT06452290 — PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder · NA · not yet recruiting
- NCT07518498 — Hypnosis During Mechanical Ventilation Weaning · NA · not yet recruiting
- NCT07471334 — Prospective Study of Postictal Psychotic Symptoms Occuring After Video-EEG Monitoring in Focal Epilepsies · NA · not yet recruiting
- NCT07414667 — Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification ( · not yet recruiting
- NCT07415759 — Imaging of Electrical Properties by MRI: Investigation of Age-Related Changes · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03974256 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 5 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03974256.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing