[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100089755":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":11,"locations":24,"responsibleParty":37,"collaborators":40,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":66,"whyStopped":67,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Institute for Neurodegenerative Disorders","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"injection of 5 mCi of 123-I mZINT","EXPERIMENTAL",null,[13],"Drug: [123I] mZINT injection and serial dynamic SPECT imaging",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","[123I] mZINT injection and serial dynamic SPECT imaging","Following bolus intravenous injection of 5 mCi of 123-I mZINT over 15 seconds, serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity. Venous blood measures will be obtained with each acquisition and characterization of 123-I mZINT and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKG.",[9],[21],{"name":22,"affiliation":5,"role":23},"John P Seibyl, MD","PRINCIPAL_INVESTIGATOR",[25],{"facility":5,"status":11,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":11},"New Haven","Connecticut","06510","United States","US",{"type":32,"coordinates":33},"Point",[34,35],-72.92816,41.30815,{"lat":35,"lon":34},{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":38,"oldOrganization":39},"John Seibyl, MD","MNI",[41],{"name":42,"class":6},"Molecular NeuroImaging","100089755","phase-1-assessment-of-the-biodistribution-and-safety-of-123-i-mzint-in-healthy-subjects-and-parkinson-disease-patients-100089755",false,"NCT00427674","Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease Patients","Phase I Evaluation of (123-I)MZINT as a Brain SPECT Tracer of Serotonin Transporters in Healthy Human Subjects","Inclusion Criteria:\n\nHealth Control:\n\n* The subject is aged 18-70.\n* Written informed consent is obtained.\n* The participant has no clinically significant clinical laboratory value and\u002For clinically significant unstable medical, neurological or psychiatric illness.\n* For females, non-child bearing potential or negative urine pregnancy test on day of \\[123I\\] mZINT injection.\n* Willingness to comply with the study protocol\n\nParkinson disease:\n\n* The subject is aged 18-70.\n* Participants have a clinical diagnosis (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) of idiopathic Parkinson's disease.\n* Hoehn and Yahr stages \\\u003C 3.\n* Written informed consent is obtained.\n* The participant has no clinically significant clinical laboratory value and\u002For clinically significant unstable medical, neurological or psychiatric illness.\n* For females, non-child bearing potential or negative urine pregnancy test on day of \\[123I\\] mZINT injection.\n\nWillingness to comply with the study protocol\n\nExclusion Criteria:\n\nAll Subjects will be excluded from participation for the following reasons:\n\n* The subject has a clinically significant clinical laboratory values abnormality, and\u002For medical or psychiatric illness.\n* The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).\n* The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.\n* Use of all prescription drugs or non-prescriptions drugs that may effect serotonin such as antidepressants including sertraline, fluoxetine, fluvoxamine, venlafaxine.\n* The participant has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) {American Psychiatric Association, 1994 #2} within the past 2 years.\n* Pregnancy",true,"ALL","18 Years","70 Years",{"count":55,"type":56},28,"ACTUAL","INTERVENTIONAL",[59],"PHASE1","The overall plan of this project is to evaluate \\[123I\\] mZINT as a tool to assess SERT density in humans. This protocol will be completed in three parts. In Part A serial dynamic SPECT will be acquired after injection of \\[123I\\] mZINT in healthy controls to assess regional brain uptake in human subjects. If Part A demonstrates robust brain region specific uptake, then Part B - additional studies in healthy subjects to assess biodistribution, and Part C - studies in PD subjects to compare regional uptake to healthy controls, will be completed.",[62],"Parkinson Disease",[64,65],"Parkinson","Imaging","TERMINATED","Scan results to date did not show reason to continue with study","2010-10-05",{"date":70,"type":71},"2010-10-06","ESTIMATED",{"date":73,"type":11},"2007-01",{"date":75,"type":56},"2009-10",{"name":5,"class":6},1]