[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053420":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":45,"armGroups":41,"interventions":41,"overallOfficials":41,"centralContacts":41,"locations":46,"responsibleParty":82,"collaborators":41,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":41,"enrollmentInfo":94,"targetDuration":41,"studyType":97,"phases":41,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"XEOS Medical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen.","The concordance rate between the specimen PET-CT images and final histopathological examination of the specimen.","Perioperative",[14,17,21,24,27,29,32,34,36,38],{"measure":15,"description":16,"timeFrame":12},"To assess the correlation between the intra-operative interpretation of specimen PET-CT images and histopathological examination of the specimen and its impact on clinical decision-making.","The concordance rate between the specimen PET-CT image interpretation and histopathological examination of the specimen. This will include sensitivity, specificity, positive predictive value, and negative predictive value of the intra-operative interpretation of specimen PET-CT images compared to final histopathological examination.\n\nThe concordance rate of the clinical decisions made based on specimen PET-CT images with the clinical decisions supported by final histopathological examination (e.g. additional resection during surgery, follow-up treatment strategy, etc).",{"measure":18,"description":19,"timeFrame":20},"To assess the correlation between long-term follow-up clinical outcome and specimen PET-CT imaging findings.","The incidence of biochemical, local, regional and distant recurrence rate at 1, 2 and 3 years of follow-up.\n\nThe measurement of functional outcome at 1, 2 and 3 years of follow-up.","From surgery to 3 years long term follow-up",{"measure":22,"description":23,"timeFrame":12},"To evaluate the influence of neoadjuvant treatment (NAT) on PET radiotracer uptake in specimen PET-CT imaging.","The measurement of PET radiotracer uptake (in MBq\u002FmL) in specimen PET-CT images, comparing patients with different neoadjuvant treatments and those who did not receive neoadjuvant treatment.",{"measure":25,"description":26,"timeFrame":12},"To investigate whether preoperatively available information (such as tumor subtype, anatomical location, tumor biology, size, grade or TNM classification) as well as intra-operatively available information influence specimen PET-CT images.","The measurement of PET-tracer uptake (in MBq\u002FmL) in specimen PET-CT images, comparing patients with various preoperatively available characteristics, as well as intra-operatively available information.",{"measure":25,"description":28,"timeFrame":12},"The measurement of electron density (in Hounsfield Units (HU)) in specimen PET-CT images, comparing patients with various preoperatively available characteristics, as well as intra-operatively available information.",{"measure":30,"description":31,"timeFrame":12},"To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images.","The measurement of radiotracer uptake (in MBq\u002FmL) in specimen PET-CT images, comparing the uptake levels and patterns across different PET radiotracers. This will assess whether the type of PET-radiotracer used leads to significant differences in the intensity or distribution of radiotracer uptake in the PET-CT specimen images.",{"measure":30,"description":33,"timeFrame":12},"The assessment of PET image quality (e.g. signal to noise ratio) in relation to PET radiotracer activity. This will involve evaluating how changes in radiotracer activity impact image quality and identifying the optimal activity for improving the PET-CT specimen imaging workflow.",{"measure":30,"description":35,"timeFrame":12},"The assessment of PET image quality (e.g. signal to noise ratio) in relation to physiological parameters (e.g. uptake time). This will involve evaluating how changes in these parameters impact image quality and identifying the optimal parameters for improving the specimen PET-CT imaging workflow.",{"measure":30,"description":37,"timeFrame":12},"The assessment of PET image quality (signal to noise ratio) in relation to imaging parameters (decay time). This will involve evaluating how changes in these parameters impact image quality and identifying the optimal parameters for improving the specimen PET-CT imaging workflow.",{"measure":39,"description":40,"timeFrame":20},"To assess the safety profile of PET-CT imaging procedures.","The incidence of related (serious and non-serious) adverse events following the specimen PET-CT imaging procedure, including the severity, type, and frequency and relationship (possible, probable, causal relationship).",null,{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":43,"timePerspective":44,"maskingInfo":41},"CASE_ONLY","OTHER","Patients who are routinely scheduled or underwent resective surgery and for whom high-resolution PET-CT imaging is or was performed on their resected specimens, using the AURA 10 PET-CT, may participate in this study.",[47,65],{"facility":48,"status":49,"city":50,"state":41,"zip":41,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"AZ Maria Middelares","RECRUITING","Ghent","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],3.71667,51.05,{"lat":57,"lon":56},[60],{"name":61,"role":62,"phone":63,"phoneExt":41,"email":64},"Dr. Ameye","CONTACT","+32 9 246 18 52","klinische.studies@mijnziekenhuis.be",{"facility":66,"status":49,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"University Hospitals Coventry and Warwickshire (UHCW) NHS Trust","Coventry","West Midlands","CV2 2DX","United Kingdom","UK",{"type":54,"coordinates":73},[74,75],-1.51217,52.40656,{"lat":75,"lon":74},[78],{"name":79,"role":62,"phone":80,"phoneExt":41,"email":81},"Oludolapo Adesanya, Dr.","+44 2476 964000","Uhcw.Research3@uhcw.nhs.uk",{"type":83,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100053420","to-assess-the-correlation-of-high-resolution-specimen-pet-ct-imaging-using-the-xeos-aura-10-pet-ct-with-the-histopathology-results-and-long-term-outcome-of-patients-undergoing-resective-cancer-surgery-100053420",false,"NCT06970275","To Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","A Multicentric, Observational, Post-marketing, Registry Study to Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","PETRiS","Inclusion Criteria :\n\nAll patients that were scheduled for resective surgery and for whom successful high-resolution PET-CT imaging was performed on their resected specimens using the AURA 10 PET-CT. Successful imaging means that the image contains at least a portion of the primary tumor, the radiotracer injection was correctly executed and there were no technical issues that lead to an uninterpretable PET-CT image. Or all patients that are scheduled for resective surgery and for whom high-resolution PET-CT imaging will be performed on their resected specimens using the AURA 10 PET-CT.\n\nPatients willing to provide informed consent for use of their relevant medical records. For retrospectively included patients with no further Long-Term Follow-Up (LTFU) data collection, a notification will be sent.\n\nExclusion Criteria:\n\n* Under the age of 18 years at the time of resective surgery.\n* Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":95,"type":96},850,"ESTIMATED","OBSERVATIONAL","This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings. Additionally, it assesses how these imaging insights influence clinical decision-making and long-term patient outcomes. Through this comprehensive analysis in a real-world setting, the study seeks to generate valuable insights that can enhance specimen evaluation processes and ultimately improve patient care.",[100,101,102,103],"Prostate Cancers","Breast Cancer","Head and Neck Cancer","Cancer",[105,106,107,108],"PET-CT","Registry","Imaging","cancer","2026-07-10",{"date":111,"type":112},"2026-07-13","ACTUAL",{"date":114,"type":112},"2025-11-19",{"date":116,"type":96},"2031-01-15",{"name":5,"class":6},2]