[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606325":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":22,"studyPopulation":23,"armGroups":24,"interventions":30,"overallOfficials":18,"centralContacts":36,"locations":46,"responsibleParty":62,"collaborators":18,"id":64,"slug":18,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":18,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":49,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002FCT)","During and immediately after radiopharmaceutical injection",[14],{"measure":15,"description":16,"timeFrame":17},"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.","within 90 minutes after radiopharmaceutical administration",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","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\u002FCT 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.\n\nThe 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.\n\nThe project is structured into three phases:\n\nPhase 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.\n\nPhase 2 (Monte Carlo Simulations): Activity and dose calibration, dose distribution modeling in extravascular tissues.\n\nPhase 3 (Dissemination): Scientific publications and presentation of results at international conferences.\n\nThis 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.","Adult patients undergoing standard-of-care nuclear medicine procedures (PET\u002FCT or therapeutic α\u002Fβ radiopharmaceutical administrations).",[25],{"label":26,"type":18,"description":27,"interventionNames":28},"Patients undergoing radiotherapy","The individuals studied will all be patients administered with radiopharmaceuticals for diagnostic and therapy purposes (aged between 18 and 90).",[29],"Other: RadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation.",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":18},"OTHER","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.",[26],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},"Mauro Iori, MD","CONTACT","0522\u002F296655","mauro.iori@ausl.re.it",{"name":43,"role":39,"phone":44,"phoneExt":18,"email":45},"Federica Fioroni, MD","0522\u002F296653","federica.fioroni@ausl.re.it",[47],{"facility":48,"status":49,"city":50,"state":18,"zip":18,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Azienda USL IRCCS di Reggio Emilia","RECRUITING","Reggio Emilia","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],10.63125,44.69825,{"lat":57,"lon":56},[60],{"name":38,"role":61,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100606325",false,"NCT07174089","New AI-based Technologies in Nuclear Medicine","New AI-based Technologies for Even Safer and More Precise Nuclear Medicine","AI-basedMedNuc","Inclusion Criteria:\n\n* patients undergoing PET\u002FCT scans or therapeutic treatments with radiopharmaceuticals labelled with alpha or beta emitting nuclides\n\nExclusion Criteria:\n\n* patients whose clinical or psychological conditions do not allow for their involvement","ALL","18 Years","90 Years",{"count":75,"type":76},1500,"ESTIMATED","OBSERVATIONAL","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\u002FCT diagnostics, providing an estimate of the correction factor necessary for accurate SUV evaluation in case of an extravasation event.",[80],"Patients Undergoing PET\u002FCT Investigation or Nuclear Medicine Therapy",[82,83,84,85,86],"extravasation","SUV","radioligand therapy","radiopharmaceutical","dosimetry","2026-05-28",{"date":89,"type":90},"2026-05-29","ACTUAL",{"date":92,"type":90},"2021-07-30",{"date":94,"type":76},"2026-12-31",{"name":5,"class":6},1]