[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571919":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":25,"id":53,"slug":25,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":25,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"2 MBq 18F-FDG","Subjects are intravenously administered with 2.0 MBq\u002Fkg 18F-FDG, standard tracer used to diagnose and stage the malignancy. After standard of care excision of the primary tumor, a high-resolution PET-CT imaging of the fresh surgical specimen will be performed.",[12],"Device: XEOS AURA 10",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","XEOS AURA 10","Surgery is performed according to standard of care. Directly after surgery, the surgical specimen is taken outside the operation theatre in a dedicated imaging room at the Department of Nuclear Medicine where high-resolution PET-CT imaging of the surgical specimen is performed.",[9],[20,21,22,23,24],"PET","PET\u002FCT","High resolution PET\u002FCT","Margin detection","Margin status",null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Jasper Vonk, Dr.","CONTACT","+31 50 36162029","j.vonk@umcg.nl",[33],{"facility":5,"status":25,"city":34,"state":25,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Groningen","9713 GZ","Netherlands",{"type":38,"coordinates":39},"Point",[40,41],6.56667,53.21917,{"lat":41,"lon":40},[44,47],{"name":45,"role":29,"phone":46,"phoneExt":25,"email":31},"Jasper Vonk, Dr","0631794010",{"name":48,"role":29,"phone":49,"phoneExt":25,"email":50},"Rik de Jong","0611523057","r.de.jong@umcg.nl",{"type":52,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100571919",false,"NCT06726512","Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy","qMAP","Inclusion Criteria:\n\n* Age ≥18 years.\n* Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or osteosarcoma.\n* Patient is indicated to undergo curative surgery of the primary tumor.\n* Patient is estimated compliant for study participation by the investigator.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;\n* Patient has previously received radiotherapy of the primary tumor region;\n* Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months;\n* A blood glucose level over 200 mg\u002FdL on the day of surgery.\n* Pregnancy or lactation.","ALL","18 Years",{"count":62,"type":63},30,"ESTIMATED","INTERVENTIONAL",[66],"NA","The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.",[69,70,71,72],"Oral Cancer","Osteosarcoma","Soft Tissue Sarcoma","Oral Squamous Cell Carcinoma (OSCC)",[74,75,76],"margin assessment","image-guided surgery","PET-CT","NOT_YET_RECRUITING","2024-12-09",{"date":80,"type":81},"2024-12-10","ACTUAL",{"date":83,"type":63},"2025-01",{"date":85,"type":63},"2026-04",{"name":5,"class":6},1]