[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650676":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":12,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":15,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"adults with high-grade MIBC",null,"adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC",[13],{"facility":14,"status":15,"city":16,"state":10,"zip":17,"country":18,"countryCode":19,"cosmosGeoPoint":20,"geoPoint":25,"contacts":26},"Azienda Ospedaliero-Universitaria di Ferrara","RECRUITING","Ferrara","44124","Italy","IT",{"type":21,"coordinates":22},"Point",[23,24],11.62057,44.83804,{"lat":24,"lon":23},[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Luca Urso, MD","CONTACT","+390532236906","luca.urso@unife.it",{"name":33,"role":29,"phone":10,"phoneExt":10,"email":34},"Francesca Canella","francesca.canella@ausl.fe.it",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100650676","diagnostic-accuracy-of-18f-fdg-petct-in-muscle-invasive-bladder-cancer-100650676",false,"NCT07750470","Diagnostic Accuracy of 18F-FDG PET\u002FCT in Muscle-invasive Bladder Cancer","Diagnostic Accuracy of 18F-FDG PET\u002FCT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study","MIBC-PET","Inclusion Criteria:\n\n* Adults aged 18 years or older Previously known oncological disease Histologically confirmed diagnosis of high-grade MIBC Non-muscle-invasive, or low-grade bladder cancer\n\nEligible for platinum-based neoadjuvant treatment on clinical evaluation:\n\n* ECOG performance status of 0-1,\n* creatinine clearance of at least 60 mL\u002Fmin,\n* absence of comorbidities that would contraindicate chemotherapy (such as grade ≥2 neuropathy, grade ≥2 hearing impairment, or significant cardiopathy) Impossibility to perform imaging procedures, including\n* Claustrophobia\n* history of iodinated contrast medium allergy precluding ceCT\n* diabetes uncontrolled by medications Sign of informed consent\n\nExclusion Criteria:\n\n* Adults aged 18 years or older Previously known oncological disease Histologically confirmed diagnosis of high-grade MIBC Non-muscle-invasive, or low-grade bladder cancer\n\nEligible for platinum-based neoadjuvant treatment on clinical evaluation:\n\n* ECOG performance status of 0-1,\n* creatinine clearance of at least 60 mL\u002Fmin,\n* absence of comorbidities that would contraindicate chemotherapy (such as grade ≥2 neuropathy, grade ≥2 hearing impairment, or significant cardiopathy) Impossibility to perform imaging procedures, including\n* Claustrophobia\n* history of iodinated contrast medium allergy precluding ceCT\n* diabetes uncontrolled by medications","ALL","18 Years",{"count":48,"type":49},60,"ESTIMATED","OBSERVATIONAL","MIBC-PET is a prospective, monocentric, no-profit study with paired imaging comparison enrolling 60 patients with newly diagnosed, histologically confirmed high-grade MIBC. All patients undergo baseline staging with \\[18F\\]FDG PET\u002FCT and contrast-enhanced CT (ceCT) of chest, abdomen, and pelvis. A second \\[18F\\]FDG PET\u002FCT and CT are performed after two cycles of neoadjuvant therapy. \\[18F\\]FDG PET\u002FCT includes both standard delayed imaging and an early dynamic pelvic acquisition to overcome urinary tracer interference. The primary endpoints are (1) diagnostic accuracy of \\[18F\\]FDG PET\u002FCT versus ceCT for baseline staging, and (2) accuracy of \\[18F\\]FDG PET\u002FCT in predicting pathological response to neoadjuvant chemotherapy. Secondary endpoints include validation of early dynamic \\[18F\\]FDG PET\u002FCT for local staging and radiomic\u002FAI-based predictive modeling.",[53],"Muscle-invasive Bladder Cancer",[55,56,57,58,59,60,61],"muscle-invasive bladder cancer","PET\u002FCT","18F-FDG PET","neoadjuvant chemotherapy","diagnostic accuracy","radiomics","artificial intelligence","2026-08-04",{"date":64,"type":65},"2026-08-06","ACTUAL",{"date":67,"type":65},"2024-04-16",{"date":69,"type":49},"2026-12",{"name":5,"class":6},1]