Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2021-07-30
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients undergoing radiotherapy
The individuals studied will all be patients administered with radiopharmaceuticals for diagnostic and therapy purposes (aged between 18 and 90).
RadEye 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.
Interventions
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RadEye 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Responsible Party
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Locations
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Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, , Italy
Countries
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Central Contacts
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References
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Wilson S, Osborne D, Long M, Knowland J, Fisher DR. Practical Tools for Patient-specific Characterization and Dosimetry of Radiopharmaceutical Extravasation. Health Phys. 2022 Nov 1;123(5):343-347. doi: 10.1097/HP.0000000000001600. Epub 2022 Jul 15.
Iori M, Grassi E, Piergallini L, Meglioli G, Botti A, Sceni G, Cucurachi N, Verzellesi L, Finocchiaro D, Versari A, Fraboni B, Fioroni F. Safety injections of nuclear medicine radiotracers: towards a new modality for a real-time detection of extravasation events and 18F-FDG SUV data correction. EJNMMI Phys. 2023 May 23;10(1):31. doi: 10.1186/s40658-023-00556-5.
Tylski P, Pina-Jomir G, Bournaud-Salinas C, Jalade P. Tissue dose estimation after extravasation of 177Lu-DOTATATE. EJNMMI Phys. 2021 Mar 31;8(1):33. doi: 10.1186/s40658-021-00378-3.
Kiser JW, Benefield T, Lattanze RK, Ryan KA, Crowley J. Assessing and Reducing Positron Emission Tomography/Computed Tomography Radiotracer Infiltrations: Lessons in Quality Improvement and Sustainability. JCO Oncol Pract. 2020 Jul;16(7):e636-e640. doi: 10.1200/JOP.19.00302. Epub 2020 Feb 11.
Williams JM, Arlinghaus LR, Rani SD, Shone MD, Abramson VG, Pendyala P, Chakravarthy AB, Gorge WJ, Knowland JG, Lattanze RK, Perrin SR, Scarantino CW, Townsend DW, Abramson RG, Yankeelov TE. Towards real-time topical detection and characterization of FDG dose infiltration prior to PET imaging. Eur J Nucl Med Mol Imaging. 2016 Dec;43(13):2374-2380. doi: 10.1007/s00259-016-3477-3. Epub 2016 Aug 25.
Osborne D, Lattanze R, Knowland J, Bryant TE, Barvi I, Fu Y, Kiser JW. The Scientific and Clinical Case for Reviewing Diagnostic Radiopharmaceutical Extravasation Long-Standing Assumptions. Front Med (Lausanne). 2021 Jun 28;8:684157. doi: 10.3389/fmed.2021.684157. eCollection 2021.
Bilgic S. FDG Extravasation in PET/CT Imaging: A Visual Grading Approach Based on Clinical Observations. J Med Imaging Radiat Oncol. 2025 Sep;69(6):617-625. doi: 10.1111/1754-9485.13876. Epub 2025 Jul 2.
van der Pol J, Voo S, Bucerius J, Mottaghy FM. Consequences of radiopharmaceutical extravasation and therapeutic interventions: a systematic review. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1234-1243. doi: 10.1007/s00259-017-3675-7. Epub 2017 Mar 16.
Other Identifiers
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267/2022/SPER/IRCCSRE
Identifier Type: -
Identifier Source: org_study_id
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