[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586444":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":57,"collaborators":60,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":32,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":32,"enrollmentInfo":74,"targetDuration":32,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Vanderbilt-Ingram Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"18F-FDG","EXPERIMENTAL","After confirming inclusion\u002Fexclusion criteria, all participants will receive a one-time IV infusion of 18 F-FDG dose prior to surgical extirpation of tumor. Administration of 18 F-FDG will be injected as a bolus during surgery. Appropriate medical resources for the treatment of severe infusion reactions should be available during infusions, although these are not expected.\n\nOnce the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET\u002FCT Imaging Device.",[13],"Device: Intra-op PET\u002FCT Specimen Scanner",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Intra-op PET\u002FCT Specimen Scanner","Once the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET\u002FCT Imaging Device. Imaging will be obtained utilizing a XEOS AURA 10 scanner in real time while in the operating room with the surgery team still present.",[9],[21],"XEOS Aura 10",[23],{"name":24,"affiliation":25,"role":26},"Michael Topf, MD","Vanderbilt University\u002FIngram Cancer Center","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Nicole Jones","CONTACT","615-936-2807",null,"nicole.l.jones@vumc.org",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Kyrionna Golliday","615-421-1585","kyrionna.m.golliday@vumc.org",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Vanderbilt University Medical Center","RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-86.78444,36.16589,{"lat":51,"lon":50},[54,55,56],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},{"name":24,"role":26,"phone":32,"phoneExt":32,"email":32},{"type":26,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Michael Topf","Assistant Professor - Head & Neck Surgical Oncology-Microvascular Reconstruction",[61,62],{"name":40,"class":6},{"name":63,"class":64},"XEOS Medical","INDUSTRY","100586444","high-resolution-pet-ct-imaging-for-surgical-margin-visualization-100586444",false,"NCT06915454","High-Resolution PET-CT Imaging for Surgical Margin Visualization","High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study","Inclusion Criteria:\n\n* Biopsy confirmed diagnosis of any solid malignancy\n* Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.\n* Planned standard of care oncologic surgery with curative intent\n* Male or female patients age ≥ 18 years\n* Have life expectancy of more than 12 weeks\n* Karnofsky performance status of at least 70% or ECOG\u002FZubrod level 1\n* Have acceptable glucose status (\\\u003C200 mg\u002FdL) at Day of Surgery prior to 18F-FDG injection\n\nExclusion Criteria:\n\n* General or local contraindications for resective surgery\n* Women who are pregnant or breast-feeding\n* Blood glucose level over 200 mg\u002FdL prior to 18F-FDG infusion\n* Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.","ALL","18 Years",{"count":75,"type":76},50,"ESTIMATED","INTERVENTIONAL",[79],"NA","Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol.\n\nPotential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins.\n\nTime Commitment: There are no additional visits that will be asked of you to partake in this study.\n\nDrug is FDA approved and Exposure to Radiation is minimal.",[82,83,84,85,86],"Cancer","Solid Malignant Tumors","SCC - Squamous Cell Carcinoma","HNSCC","HNSCC,Larynx, Pharynx and Oral Cavity",[88,89,90,91,92,93,94,95,96,97,98,99,100],"undergoing surgery","Xeos","PET\u002FCT imaging","specimen scanner","cancer margins","oral cancer","mouth cancer","tongue cancer","gum cancer","scc","head and neck cancer","pharynx","hnscc","2026-05-06",{"date":103,"type":104},"2026-05-08","ACTUAL",{"date":106,"type":104},"2025-09-03",{"date":108,"type":76},"2027-07",{"name":5,"class":6},1]