[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403376":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":49,"collaborators":19,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":19,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":19,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University of Michigan","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Group 1","These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of \\[18F\\]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.",[12],"Drug: FNP-59",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","FNP-59","FNP-59, a radiotracer, is administered for PET\u002FCT scans.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Ben Viglianti, M.D, Ph.D.","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Jim Pool","CONTACT","734-615-7391","jampool@umich.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-83.74088,42.27756,{"lat":42,"lon":41},[45,47],{"name":46,"role":27,"phone":28,"phoneExt":19,"email":29},"James Pool",{"name":48,"role":23,"phone":19,"phoneExt":19,"email":19},"Benjamin Viglianti, M.D, Ph.D.",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Benjamin Viglianti","Assistant Professor of Radiology","100403376","early-phase-1-positron-emission-tomography-pet-imaging-of-cholesterol-trafficking-clinical-evaluation-of-18ffnp-59-in-normal-human-subjects-group-1-100403376",false,"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",true,"ALL","18 Years",{"count":63,"type":64},6,"ESTIMATED","INTERVENTIONAL",[67],"EARLY_PHASE1","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.",[70,71,72],"Radiotracer","Hypertension","Cholesterol","2025-11-27",{"date":75,"type":76},"2025-12-05","ACTUAL",{"date":78,"type":76},"2021-01-18",{"date":80,"type":64},"2026-12",{"name":51,"class":6},1]