[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100148559":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":26,"centralContacts":11,"locations":31,"responsibleParty":65,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":11,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":89,"whyStopped":11,"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",null,[13],"Drug: Bombesin (68Ga) labeled (BAY86-7548)",{"label":15,"type":10,"description":11,"interventionNames":16},"Arm 2",[13],[18,23],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Bombesin (68Ga) labeled (BAY86-7548)","Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET\u002FCT",[9],{"type":19,"name":20,"description":24,"armGroupLabels":25,"otherNames":11},"Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET\u002FCT for determination of effective dose, kinetics of BAY86-7548 in blood",[15],[27],{"name":28,"affiliation":29,"role":30},"Bayer Study Director","Bayer","STUDY_DIRECTOR",[32,43,54],{"facility":11,"status":11,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":11},"Turku","FIN-20521","Finland","FI",{"type":38,"coordinates":39},"Point",[40,41],22.26869,60.45148,{"lat":41,"lon":40},{"facility":11,"status":11,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":53,"contacts":11},"Ulm","Baden-Wurttemberg","89081","Germany","DE",{"type":38,"coordinates":50},[51,52],9.99155,48.39841,{"lat":52,"lon":51},{"facility":11,"status":11,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":11},"Zurich","Canton of Zurich","8091","Switzerland","CH",{"type":38,"coordinates":61},[62,63],8.55,47.36667,{"lat":63,"lon":62},{"type":66,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100148559","phase-1-petct-imaging-for-radiation-dosimetry-plasma-pharmacokinetics-biodistribution-safety-and-tolerability-and-diagnostic-performance-of-bay86-7548-in-patients-with-prostate-cancer-and-healthy-volunteers-100148559",false,"NCT01205321","PET\u002FCT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers","Open-label, Multi Center PET\u002FCT (Positron Emission Tomography\u002FComputed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET\u002FCT in Healthy Volunteers","Inclusion Criteria:\n\n* Healthy volunteers:\n\n  * males, \\>\u002F=50 and \\\u003C\u002F= 65 years of age\n* Cancer patients:\n\n  * males \\>\u002F= 45 years of age\n  * Patients had an MRI of the prostate and\u002For a positive choline or acetate PET\u002FCT for diagnosis (Note: MRI, choline and acetate PET\u002FCT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is\u002F will be histologically confirmed.\n  * The prostate cancer is histologically confirmed and results of histology are available.\n  * Patients with primary prostate cancer: \\>\u002F= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation.\n  * Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.\n\nExclusion Criteria:\n\n* Concurrent severe and\u002For uncontrolled and\u002For unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY86-7548, 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.","MALE","45 Years",{"count":77,"type":78},19,"ACTUAL","INTERVENTIONAL",[81],"PHASE1","Visual assessment of diagnostic PET\u002FCT (positron emission tomography\u002Fcomputed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.",[84],"Diagnostic Imaging",[86,87,88],"Neoplasm","PET\u002FCT diagnosis","PET tracer","COMPLETED","2013-01-18",{"date":92,"type":93},"2013-01-21","ESTIMATED",{"date":95,"type":11},"2010-11",{"date":97,"type":78},"2011-12",{"name":5,"class":6},3]