[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiotracer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiotracer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100609626","phase-1-study-evaluating-18fnota-aby030-for-safety-and-tolerability-of-indeterminate-primary-andor-metastatic-disease-in-head-and-neck-squamous-cell-carcinoma-100609626",false,"NCT07217028","Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and\u002For Metastatic Disease in Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.\n3. Must have evidence of indeterminate metastatic and\u002For primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal\n4. Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):\n\n   1. Hemoglobin ≥ 9gm\u002FdL\n   2. White blood cell count \\> 3000\u002Fmm3\n   3. Platelet count ≥ 100,000\u002Fmm3\n   4. Serum creatinine ≤ 1.5 times upper reference range\n   5. Potassium\n   6. Magnesium\n   7. Phosphorus\n\nExclusion Criteria:\n\n1. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.\n2. Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.\n3. Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.\n4. Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.\n5. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n6. Severe renal disease or anuria.\n7. Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.\n8. Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.","ALL","18 Years",{"count":18,"type":19},25,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of \\[18F\\]NOTA-ABY030 PET\u002FCT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a radiolabeled anti-EGFR affibody designed for rapid clearance and improved tumor-to-background contrast. All participants will receive a 50 mg cetuximab loading dose followed by a bolus of \\[18F\\]NOTA-ABY030, with PET\u002FCT imaging performed at defined intervals to assess biodistribution and lesion uptake. The primary objective is to determine safety and tolerability; secondary objectives include radiation dosimetry and comparison of sensitivity and specificity to conventional imaging modalities (MRI, CT, and \\[18F\\]FDG-PET\u002FCT). This approach aims to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline treatment decisions for patients with HNSCC.",[25,26,27,28],"SCC - Squamous Cell Carcinoma","Radiotracer","Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma",[30,31,32,33],"unknown primary","cancer","hnscc","scc","RECRUITING","2026-05-06",{"date":37,"type":38},"2026-05-11","ACTUAL",{"date":40,"type":38},"2026-04-24",{"date":42,"type":19},"2030-09",{"name":44,"class":45},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100404420","early-phase-1-positron-emission-tomography-pet-imaging-of-cholesterol-trafficking-clinical-evaluation-of-18ffnp-59-in-normal-human-subjects-groups-2-3--4-100404420","NCT04546126","Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)","Inclusion Criteria (Groups 2 \\& 3):\n\n* Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation\n\nExclusion Criteria (Groups 2 \\& 3):\n\n* Pregnancy\n* Unable to do imaging\n* Body weight greater than 400 lbs (181 Kg)\n* Prisoners are not eligible\n* Subjects unable to provide own consent are not eligible\n* Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)\u002F Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.\n* Known adrenal pathology\n\nInclusion Criteria (Group 4):\n\n* Abnormal adrenal cortical hormone secretion\n\nExclusion Criteria (Group 4):\n\n* Pregnant",true,{"count":55,"type":19},24,[57],"EARLY_PHASE1","This study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\\[18F\\]FNP-59) to image the adrenal gland. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.",[26,60,61],"Hypertension","Cholesterol","2025-11-27",{"date":64,"type":38},"2025-12-05",{"date":66,"type":38},"2021-11-01",{"date":68,"type":19},"2026-12",{"name":70,"class":45},"Benjamin Viglianti",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":53,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":20,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":87,"locationsCount":46},"100403376","early-phase-1-positron-emission-tomography-pet-imaging-of-cholesterol-trafficking-clinical-evaluation-of-18ffnp-59-in-normal-human-subjects-group-1-100403376","NCT04532489","Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)","Inclusion Criteria:\n\n* Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes\n\nExclusion Criteria:\n\n* Pregnancy\n* Unable to do imaging\n* Body weight greater than 400 lbs (181 Kg)\n* Prisoners are not eligible\n* Subjects unable to provide own consent are not eligible\n* Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)\u002F Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.\n* Known adrenal pathology",{"count":79,"type":19},6,[57],"This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\\[18F\\]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that \\[18F\\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.",[26,60,61],{"date":64,"type":38},{"date":85,"type":38},"2021-01-18",{"date":68,"type":19},{"name":70,"class":45}]