[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404420":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":76,"collaborators":29,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":29,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":29,"enrollmentInfo":89,"targetDuration":29,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":29,"overallStatus":50,"whyStopped":29,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexamethasone (Group 2)","EXPERIMENTAL","Participants will undergo an FNP-59 scan on day 0 in the am. Participants will then take\n\n1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. Participants will then have a second FNP-59 scan on day 4 in the am.",[13,14],"Drug: Dexamethasone (Group 2)","Combination Product: PET\u002FCT Scan with FNP-59",{"label":16,"type":10,"description":17,"interventionNames":18},"Cosyntropin (Group 3)","Participants will undergo an FNP-59 scan on day 0 in the am. On day 4 the participant will arrive for imaging. Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.",[19,14],"Drug: Cosyntropin (Group 3)",{"label":21,"type":10,"description":22,"interventionNames":23},"Adrenal pathology (Group 4)","Whole-body PET\u002FCT scans will be done on 4 patients at 1 hr and the other 4 patients at 6 hours. All the patients will have a whole-body PET\u002FCT scan at 3 hours.",[14],[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.",[9],null,{"type":26,"name":16,"description":31,"armGroupLabels":32,"otherNames":29},"Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.",[16],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"COMBINATION_PRODUCT","PET\u002FCT Scan with FNP-59","FNP-59, a radiotracer, is administered for PET\u002FCT scans.",[21,16,9],[39],{"name":40,"affiliation":5,"role":41},"Benjamin L Viglianti, M.D, Ph.D.","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":29,"email":47},"Jim Pool","CONTACT","734-615-7391","jampool@umich.edu",[49,66],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-83.74088,42.27756,{"lat":60,"lon":59},[63,65],{"name":64,"role":45,"phone":46,"phoneExt":29,"email":47},"James Pool",{"name":40,"role":41,"phone":29,"phoneExt":29,"email":29},{"facility":67,"status":68,"city":69,"state":52,"zip":70,"country":54,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":29},"BAMF Health, Inc.","COMPLETED","Grand Rapids","49503",{"type":57,"coordinates":72},[73,74],-85.66809,42.96336,{"lat":74,"lon":73},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Benjamin Viglianti","Assistant Professor of Radiology","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",false,"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,"ALL","18 Years",{"count":90,"type":91},24,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97,98,99],"Radiotracer","Hypertension","Cholesterol","2025-11-27",{"date":102,"type":103},"2025-12-05","ACTUAL",{"date":105,"type":103},"2021-11-01",{"date":107,"type":91},"2026-12",{"name":78,"class":6},2]