Patients Undergoing PET/CT Investigation or Nuclear Medicine Therapy
Conditions
Keywords
extravasation, SUV, radioligand therapy, radiopharmaceutical, dosimetry
Brief summary
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.
Detailed description
This is a descriptive, observational, non-profit study aimed at detecting and predicting extravasation events during the administration of radiopharmaceuticals for diagnostic and therapeutic purposes in nuclear medicine. Extravasation can lead to local tissue damage and compromise the accuracy of semi-quantitative imaging parameters such as the Standardized Uptake Value (SUV), widely used in PET/CT for diagnosis, staging, and therapy response evaluation. Literature reports that extravasation may cause a 21-50% change in SUV, potentially leading to incorrect assessment of tumor response. The study will use a CE-marked portable spectroscopic personal radiation detector (RadEye SPRD-ER, Thermo Fisher Scientific™), already validated in a previous Ethics Committee-approved study, to record dose-rate (DR) curves during radiopharmaceutical injections. Using these data, new dosimetric metrics will be developed to characterize correct, abnormal, and extravasation events. Machine learning (ML) algorithms will be trained on patient clinical data, injection metrics, and DR curves to classify injection events in real time and to estimate correction factors for SUV quantification. Monte Carlo simulations (MCNP code, anthropomorphic phantoms, and reconstructed patient geometries) will be performed to evaluate absorbed dose distributions in extravascular regions. The project is structured into three phases: Phase 1 (Data Acquisition & Analysis): Real-time monitoring with RadEye SPRD-ER, extraction of quantitative metrics (DRmax, DRmean, Δp, t\*, Δt), development of ML classifiers and regression models for SUV correction. Phase 2 (Monte Carlo Simulations): Activity and dose calibration, dose distribution modeling in extravascular tissues. Phase 3 (Dissemination): Scientific publications and presentation of results at international conferences. This study has the potential to improve safety, diagnostic reliability, and accuracy of radiopharmaceutical administrations by introducing predictive monitoring and real-time correction of quantitative imaging parameters.
Interventions
OTHERRadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation.
Acquisition of data during the infusion of PET radiotracers and the administration of α and β emitting radiopharmaceuticals for therapy.
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing PET/CT scans or therapeutic treatments with radiopharmaceuticals labelled with alpha or beta emitting nuclides
Exclusion criteria
* patients whose clinical or psychological conditions do not allow for their involvement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of new semi-quantitative metrics to detect extravasation events | During and immediately after radiopharmaceutical injection | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between extravasation severity and SUV alterations in nuclear medicine diagnostics | within 90 minutes after radiopharmaceutical administration | 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. |
Countries
Italy
Contacts
CONTACTMauro Iori, MD
CONTACTFederica Fioroni, MD
Outcome results
None listed