[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571919":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"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,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Groningen","9713 GZ","Netherlands","NL",{"type":39,"coordinates":40},"Point",[41,42],6.56667,53.21917,{"lat":42,"lon":41},[45,48],{"name":46,"role":29,"phone":47,"phoneExt":25,"email":31},"Jasper Vonk, Dr","0631794010",{"name":49,"role":29,"phone":50,"phoneExt":25,"email":51},"Rik de Jong","0611523057","r.de.jong@umcg.nl",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100571919","quantitative-margin-assessment-using-high-resolution-positron-emission-tomography---computed-tomograhy-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":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71,72,73,74],"Oral Cancer","Osteosarcoma","Soft Tissue Sarcoma","Oral Squamous Cell Carcinoma (OSCC)",[76,77,78],"margin assessment","image-guided surgery","PET-CT","NOT_YET_RECRUITING","2024-12-09",{"date":82,"type":83},"2024-12-10","ACTUAL",{"date":85,"type":65},"2025-01",{"date":87,"type":65},"2026-04",{"name":5,"class":6},1]