[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656640":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":24,"overallOfficials":13,"centralContacts":30,"locations":36,"responsibleParty":69,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":13,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":13,"enrollmentInfo":84,"targetDuration":13,"studyType":87,"phases":13,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":93,"whyStopped":13,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Jewish General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic accuracy of 18F-FDG PET\u002FCT for diabetic foot osteomyelitis","Diagnostic performance of 18F-FDG PET\u002FCT for diabetic foot osteomyelitis will be assessed by calculating sensitivity, specificity, positive predictive value, and negative predictive value. PET\u002FCT findings will be compared with a reference standard consisting of histopathology from bone biopsy when available, unequivocal cortical erosion\u002Fdestruction on CT, or clinical and radiographic\u002FCT confirmation during follow-up.","At least 6 months after PET\u002FCT",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Adults with diabetes and suspected diabetic foot infection with concern for osteomyelitis who have been referred by their treating physician for 18F-FDG PET\u002FCT at participating academic centers in Canada and the United States. Approximately 150 consecutive eligible participants will be prospectively enrolled. Clinical care, including the decision to perform bone biopsy or other investigations and treatments, will remain at the discretion of the treating physicians.",[19],{"label":20,"type":13,"description":21,"interventionNames":22},"Patients with suspected diabetic foot osteomyelitis","Adults with diabetes and suspected diabetic foot infection with concern for osteomyelitis who are referred by their treating physician for 18F-FDG PET\u002FCT. Participants will undergo standard clinical care and will be followed through medical record review for at least 6 months to establish the final diagnosis and clinical outcomes.",[23],"Diagnostic Test: 18F-FDG PET\u002FCT",[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":13},"DIAGNOSTIC_TEST","18F-FDG PET\u002FCT","18F-FDG PET\u002FCT of the feet performed using current-generation digital PET\u002FCT systems and a standardized acquisition protocol. PET\u002FCT images will subsequently be evaluated using standardized interpretation criteria to determine diagnostic performance for diabetic foot osteomyelitis.",[20],[31],{"name":32,"role":33,"phone":34,"phoneExt":13,"email":35},"Gad Abikhzer, MD","CONTACT","514-340-8222","gad.abikhzer@mcgill.ca",[37,50,60,64],{"facility":38,"status":13,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":13},"UT Southwestern Medical Center","Dallas","Texas","75390","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-96.80667,32.78306,{"lat":48,"lon":47},{"facility":51,"status":13,"city":52,"state":13,"zip":13,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":13},"Hôpital du Sacré-Cœur de Montréal","Montreal","Canada","CA",{"type":45,"coordinates":56},[57,58],-73.58781,45.50884,{"lat":58,"lon":57},{"facility":5,"status":13,"city":52,"state":13,"zip":13,"country":53,"countryCode":54,"cosmosGeoPoint":61,"geoPoint":63,"contacts":13},{"type":45,"coordinates":62},[57,58],{"lat":58,"lon":57},{"facility":65,"status":13,"city":52,"state":13,"zip":13,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":68,"contacts":13},"McGill University Health Centre",{"type":45,"coordinates":67},[57,58],{"lat":58,"lon":57},{"type":70,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[72],{"name":73,"class":74},"Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research Fund","UNKNOWN","100656640","18f-fdg-petct-for-diagnosis-of-diabetic-foot-osteomyelitis-100656640",false,"NCT07828691","18F-FDG PET\u002FCT for Diagnosis of Diabetic Foot Osteomyelitis","18F-FDG PET\u002FCT for Diagnosis of Diabetic Foot Osteomyelitis: A Prospective Multicenter Study of Diagnostic Accuracy","Inclusion Criteria:\n\nAge ≥18 years Diagnosis of diabetes mellitus Referred by the treating physician for clinically indicated 18F-FDG PET\u002FCT of the foot for diabetic foot infection with concern for possible osteomyelitis\n\nExclusion Criteria:\n\nHistory of previous bone infection in the study foot within the past 6 months Congenital bone disease such as osteogenesis imperfecta Active pregnancy Recent surgery in the foot with suspected osteomyelitis within the past 6 months Inability to provide informed consent or undergo PET\u002FCT imaging","ALL","18 Years",{"count":85,"type":86},150,"ESTIMATED","OBSERVATIONAL","Diabetic foot osteomyelitis (DFO) is a bone infection of the foot that can occur in people with diabetes and may lead to serious complications, including amputation. Diagnosing DFO can be difficult. This prospective multicenter observational study will evaluate how accurately 18F-FDG PET\u002FCT can diagnose DFO in patients who are already referred for this imaging test as part of their clinical care. The study will use current-generation digital PET\u002FCT systems and standardized interpretation criteria. PET\u002FCT findings will be compared with bone biopsy results when available, or with clinical and imaging findings obtained during at least 6 months of follow-up.",[90],"Diabetic Foot Infections",[92],"FDG, PET\u002FCT, diabetic feet, osteomyeltis","NOT_YET_RECRUITING","2026-09-15",{"date":96,"type":97},"2026-09-18","ACTUAL",{"date":99,"type":86},"2026-11",{"date":101,"type":86},"2029-04",{"name":5,"class":6},4]