NCT06371703

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 3, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

April 10, 2024

Last Update Submit

October 2, 2024

Conditions

Radiation Exposure

Outcome Measures

Primary Outcomes (1)

  • Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv).

    3 months

Interventions

automated system in reducing radiation exposureRADIATION

evaluate the effectiveness of the automated system in reducing radiation exposure for radiographers involved in PET/CT procedures.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthcare professionals working in nuclear medicine departments

You may qualify if:

  • )Nuclear medicine radiographers with experience in manual prepa-ration of radiopharmaceuticals.
  • \) Nuclear medicine healthcare professionals with experience in radiopharmaceutical administration.
  • \) Ability to provide written informed consent.

You may not qualify if:

  • \) Nuclear medicine radiographers without experience in manual preparation of radiopharmaceuticals.
  • \) Nuclear medicine healthcare professionals without experience in radiopharmaceutical administration.
  • \) Inability to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs San Raffaele

Milan, Italy

Location

Study Officials

  • Arturo Chiti

    IRCCS Ospedale San Raffaele

    STUDY DIRECTOR

Central Study Contacts

Giuseppe Bonfitto

CONTACT

02-26438384bonfitto.giuseppe@hsr.it

Serena Pichierri

CONTACT

02-26438384pichierri.serena@hsr.it

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 17, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

October 3, 2024

Record last verified: 2024-04

Locations

IT(1)