New AI-based Technologies in Nuclear Medicine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAzienda USL Reggio Emilia - IRCCS
About this trial
The study aims to identify and predict radiopharmaceutical extravasation events using new semi-quantitative parameters and machine learning models. It involves dose rate measurements to develop metrics for real-time monitoring. It also investigates the correlation between extravasation and SUV correction in PET/CT diagnostics, providing an estimate of the correction factor necessary for accurate SUV evaluation in case of an extravasation event.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients undergoing PET/CT scans or therapeutic treatments with radiopharmaceuticals labelled with alpha or beta emitting nuclides
Disqualifiers
patients whose clinical or psychological conditions do not allow for their involvement
Trial population
Adult patients undergoing standard-of-care nuclear medicine procedures (PET/CT or therapeutic α/β radiopharmaceutical administrations).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
RadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation.
Other interventionAcquisition of data during the infusion of PET radiotracers and the administration of α and β emitting radiopharmaceuticals for therapy.
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Patients undergoing radiotherapy1 intervention
Trial outcomes
Primary outcomes
1
Characterization of new semi-quantitative metrics to detect extravasation events
Identification and validation of quantitative parameters derived from dose-rate (DR) curves capable of reliably distinguishing between normal injection, abnormal venous retention, and extravasation events. Metrics will be applicable to both therapeutic radiopharmaceuticals (α and β emitters) and diagnostic radiotracers (e.g., PET/CT)
Time frame
During and immediately after radiopharmaceutical injectionSecondary outcomes
1
Correlation between extravasation severity and SUV alterations in nuclear medicine diagnostics
Identification and quantification of the relationship between the extent of radiopharmaceutical extravasation and changes in Standardized Uptake Value (SUV) in diagnostic imaging. This analysis will be performed using Monte Carlo simulations and OLINDA software for activity estimation and dosimetric calibration. Patient-specific imaging data (CT, PET) will be used to model extravasation events and evaluate their impact on SUV quantification.
Time frame
within 90 minutes after radiopharmaceutical administrationSponsors and contacts
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Source ClinicalTrials.gov