Radiation ExposureNCT06371703
Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System
An observational study of Radiation Exposure, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- automated system in reducing radiation exposure
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2024to Oct 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Healthcare professionals working in nuclear medicine departments
Who may be able to join
- 1)Nuclear medicine radiographers with experience in manual prepa-ration of radiopharmaceuticals.
- 2) Nuclear medicine healthcare professionals with experience in radiopharmaceutical administration.
- 3) Ability to provide written informed consent.
Who cannot join
- 1) Nuclear medicine radiographers without experience in manual preparation of radiopharmaceuticals.
- 2) Nuclear medicine healthcare professionals without experience in radiopharmaceutical administration.
- 3) Inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automated Radiopharmaceutical Preparation and Administration System
This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. This study will help to fill the existing gap in the scientific literature and provide useful guidance for the selection of the safest and most effective automated infusion system.
- Conditions
- Radiation Exposure
- Being tested
- automated system in reducing radiation exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated system in reducing radiation exposureRadiation
evaluate the effectiveness of the automated system in reducing radiation exposure for radiographers involved in PET/CT procedures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
- Investigators
- Arturo Chiti, Study director, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371703
- Sponsor's protocol ID
- PETCT_INTEGO
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automated Radiopharmaceutical Preparation and Administration System
- ClinicalTrials.gov ID
- NCT06371703
- Acronym / sponsor ID
- PETCT_INTEGO
- Conditions
- Radiation Exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 17 Apr 2024 (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.
This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. This study will help to fill the existing gap in the scientific literature and provide useful guidance for the selection of the safest and most effective automated infusion system.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthcare professionals working in nuclear medicine departments
Key inclusion criteria (3 listed)
- 1)Nuclear medicine radiographers with experience in manual prepa-ration of radiopharmaceuticals.
- 2) Nuclear medicine healthcare professionals with experience in radiopharmaceutical administration.
- 3) Ability to provide written informed consent.
Key exclusion criteria (3 listed)
- 1) Nuclear medicine radiographers without experience in manual preparation of radiopharmaceuticals.
- 2) Nuclear medicine healthcare professionals without experience in radiopharmaceutical administration.
- 3) Inability to provide written informed consent.
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 |
|---|---|---|
| automated system in reducing radiation exposureevaluate the effectiveness of the automated system in reducing radiation exposure for radiographers involved in PET/CT procedures. | Radiation | – |
Primary outcome
Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv).
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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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.
Arturo Chiti study director
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Exposure, run by IRCCS San Raffaele at 1 site in Italy.
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 3 inclusion and 3 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 3 Oct 2024. 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 Italy. 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 Giuseppe Bonfitto (02-26438384, bonfitto.giuseppe@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv). (time frame: 3 months). 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 3 Oct 2024.