[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100140774":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":22,"locations":29,"responsibleParty":62,"collaborators":22,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":22,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":22,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":89,"whyStopped":22,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Lantheus Biosciences Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET\u002FCT",[13],"Drug: BAY94-9392",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2","Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET\u002FCT for determination of effective dose, kinetics of BAY94-9392 in blood",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":22},"DRUG","BAY94-9392",null,[9,15],[25],{"name":26,"affiliation":27,"role":28},"Bayer Study Director","Bayer","STUDY_DIRECTOR",[30,42,53],{"facility":22,"status":22,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":22},"Stanford","California","94305","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-122.16608,37.42411,{"lat":40,"lon":39},{"facility":22,"status":22,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":52,"contacts":22},"München","Bavaria","81675","Germany","DE",{"type":37,"coordinates":49},[50,51],13.46314,48.69668,{"lat":51,"lon":50},{"facility":22,"status":22,"city":54,"state":22,"zip":55,"country":56,"countryCode":22,"cosmosGeoPoint":57,"geoPoint":61,"contacts":22},"Seoul","138-736","South Korea",{"type":37,"coordinates":58},[59,60],126.9784,37.566,{"lat":60,"lon":59},{"type":63,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100140774","phase-1-radiation-dosimetry-metabolism-pharmacokinetics-safety-and-tolerability-and-pet-imaging-with-bay94-9392-in-healthy-volunteers-and-patients-with-cancer-or-inflammation-100140774",false,"NCT01103310","Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation","Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET\u002FCT (Positron Emission Tomography \u002F Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET\u002FCT in Cancer Patients or Patients With Inflammation.","Inclusion criteria:\n\nIn Germany Healthy volunteers\n\n* Males\u002Ffemales ≥ 50 and ≤ 65 years Patients\n* Males\u002Ffemales ≥ 35 and ≤ 75 years\n* histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or\n* patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or\n* inflammation with a positive FDG-PET\n\nIn Korea Patients\n\n* Males\u002Ffemales ≥ 35 and ≤ 75 years\n* histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive FDG-PET or\n* patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or\n* inflammation (positive FDG-PET mandatory, could be also done as screening examination)\n\nExclusion criteria:\n\n* Concurrent severe and\u002For uncontrolled and\u002For unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 94-9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study\n* Known sensitivity to the study drug or components of the preparation",true,"ALL","35 Years","75 Years",{"count":76,"type":77},46,"ACTUAL","INTERVENTIONAL",[80],"PHASE1","Visual assessment of diagnostic PET\u002FCT (positron emission tomography\u002Fcomputed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.",[83,84],"Diagnostic Imaging","Neoplasms",[86,87,88],"Neoplasm","PET\u002FCT diagnosis","PET tracer","COMPLETED","2014-11-11",{"date":92,"type":93},"2014-11-13","ESTIMATED",{"date":95,"type":22},"2010-04",{"date":97,"type":77},"2011-08",{"name":5,"class":6},3]