[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508524":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":65,"centralContacts":70,"locations":76,"responsibleParty":96,"collaborators":99,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":29,"eligibilityCriteria":107,"healthyVolunteers":104,"sex":108,"minAge":109,"maxAge":29,"enrollmentInfo":110,"targetDuration":29,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":29,"overallStatus":78,"whyStopped":29,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Vanderbilt-Ingram Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Diagnostic (panitumumab, 111In-panitumumab, SPECT\u002FCT, surgery)","EXPERIMENTAL","Patients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT\u002FCT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.",[13,14,15,16,17,18,19,20,21,22],"Biological: Panitumumab","Other: Indium In 111 Panitumumab","Procedure: Single Photon Emission Computed Tomography","Procedure: Computed Tomography","Procedure: Surgical Procedure","Other: Imaging agent","Procedure: Intraoperative Imaging","Procedure: Near Infrared Imaging","Procedure: Electrocardiography","Procedure: Biospecimen Collection",[24,30,33,38,41,45,49,53,57,61],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","Panitumumab","Given by IV",[9],null,{"type":6,"name":31,"description":27,"armGroupLabels":32,"otherNames":29},"Indium In 111 Panitumumab",[9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"PROCEDURE","Single Photon Emission Computed Tomography","Undergo SPECT\u002FCT",[9],{"type":34,"name":39,"description":36,"armGroupLabels":40,"otherNames":29},"Computed Tomography",[9],{"type":34,"name":42,"description":43,"armGroupLabels":44,"otherNames":29},"Surgical Procedure","Undergo standard of care surgery",[9],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":29},"Imaging agent","Receive local injection of optical dye",[9],{"type":34,"name":50,"description":51,"armGroupLabels":52,"otherNames":29},"Intraoperative Imaging","Undergo Intraoperative Imaging",[9],{"type":34,"name":54,"description":55,"armGroupLabels":56,"otherNames":29},"Near Infrared Imaging","Undergo Near Infrared Imaging",[9],{"type":34,"name":58,"description":59,"armGroupLabels":60,"otherNames":29},"Electrocardiography","Undergo Electrocardiography",[9],{"type":34,"name":62,"description":63,"armGroupLabels":64,"otherNames":29},"Biospecimen Collection","Undergo blood sample collection",[9],[66],{"name":67,"affiliation":68,"role":69},"Eben Rosenthal, MD","Vanderbilt University\u002FIngram Cancer Center","PRINCIPAL_INVESTIGATOR",[71],{"name":72,"role":73,"phone":74,"phoneExt":29,"email":75},"Nicole Jones","CONTACT","615-936-2807","nicole.l.jones@vumc.org",[77],{"facility":68,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-86.78444,36.16589,{"lat":88,"lon":87},[91,95],{"name":92,"role":73,"phone":93,"phoneExt":29,"email":94},"Vanderbilt-Ingram Service Services for Timely Access","800-811-8480","cip@vumc.org",{"name":67,"role":69,"phone":29,"phoneExt":29,"email":29},{"type":69,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Eben Rosenthal","Professor of Medicine",[100],{"name":101,"class":6},"American Cancer Society, Inc.","100508524","phase-1-evaluating-111in-panitumumab-for-nodal-staging-in-head-and-neck-cancer-100508524",false,"NCT05901545","Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer","Inclusion Criteria:\n\n* Age ≥ 19 years.\n* Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).\n* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.\n* Planned standard of care elective neck dissection for node-negative or node-positive disease.\n* Have acceptable hematologic status, kidney function, and liver function including the following clinical results:\n\n  * Hemoglobin ≥ 9 gm\u002FdL\n  * White blood cell count \\> 3000\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Serum creatinine ≤ 1.5 times upper reference range\n\nExclusion Criteria:\n\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.\n* History of infusion reactions to monoclonal antibody therapies\n* History of allergies to iodine\n* Pregnant or breastfeeding.\n* Magnesium or potassium lower than the normal institutional values.\n* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n* Severe renal disease or anuria.","ALL","19 Years",{"count":111,"type":112},30,"ESTIMATED","INTERVENTIONAL",[115],"PHASE1","This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography\u002Fcomputed tomography (SPECT\u002FCT). SPECT\u002FCT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT\u002FCT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.",[118,119],"Head and Neck Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","2026-03-03",{"date":122,"type":123},"2026-03-05","ACTUAL",{"date":125,"type":123},"2023-08-22",{"date":127,"type":112},"2029-11-30",{"name":5,"class":6},1]