[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599186":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":11,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Lutroo Imaging LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy subjects","EXPERIMENTAL",null,[13],"Diagnostic Test: Intravenous Radiocaine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DIAGNOSTIC_TEST","Intravenous Radiocaine","Intravenous injection of Radiocaine",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Chief Medical Officer","CONTACT","877-310-1326","info@lutrooimaging.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Stanford University School of Medicine","RECRUITING","Stanford","California","94305","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-122.16608,37.42411,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":11,"email":45},"Clinical Associate Professor of Radiology","(650) 724-4421","srj8@stanford.edu",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[49],{"name":50,"class":51},"Stanford University","OTHER","100599186","early-phase-1-radiocaine-safety-study-100599186",false,"NCT07081217","Radiocaine Safety Study","[18F]Radiocaine: Radiation and Radiochemical Safety","Inclusion Criteria:\n\n* 18 years and older\n* Able to provide written consent\n* Willing and able to undergo ECG, imaging, blood sampling, and complete self-assessment rating scales at the specified time points\n* Unremarkable baseline health without report of chronic or acute pain\n* Willing and able to participate in all imaging procedures and complete the self-assessment rating scales at the specified time points\n\nExclusion Criteria:\n\n* Body mass index (BMI) of 32 or greater, weight \\>300 lbs\n* Diagnosis of severe depression\u002Fanxiety (PROMIS score \\> 95%) or suicidal ideation\n* History of opioid abuse or opioid use disorder\n* History of seizures or epilepsy\n* History of major Axis I or Axis II psychiatric disorder that might, in the opinion of the investigator, make it difficult for the subject to complete all the procedures (e.g. obsessive-compulsive disorder, bipolar disorder, schizophrenia, or schizoaffective disorder)\n* History of cardiac arrhythmia\n* History of major orthopedic surgery within the last 12 months\n* Recent history (previous 6 months) of sodium channel blocker use, including, but not limited to: carbamazepine, lamotrigine, lidocaine, phenytoin, propranolol, or valproate\n* Any significant systemic illness or medical condition that could lead to difficulty complying with the study protocol\n* Creatinine clearance (calculated using the Cockcroft-Gault formula or measured) \\\u003C 60 mL\u002Fmin or serum creatinine \\>1.5 x ULN\n* QTcF \\>470 msec for females and QTcF \\>450 msec for males on screening ECG\n* MRI-incompatible implants, large tattoos, previous shrapnel injury\n* Pregnancy or lactating\n* History of contact sport participation, such as football, hockey, or rugby\n* Known claustrophobia related to MR or PET-MRI scanners\n* Recent blood donation\u002Fdraw of \\>1 unit (previous 4 weeks)\n* History of hypersensitivity to local anesthetics of the amide type\n* Family or personal history of familial malignant hyperthermia",true,"ALL","18 Years",{"count":63,"type":64},6,"ESTIMATED","INTERVENTIONAL",[67],"EARLY_PHASE1","This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels. The study enrolls adult volunteers and aims to inform future clinical development in molecular imaging applications. Radiocaine™ is being developed as a potential diagnostic imaging agent and imaging biomarker for the localization and quantification of sodium channel activity.",[70],"Healthy Subjects",[72,73,74,75],"Radiocaine","PET imaging","medical imaging","diagnostic imaging","2026-05-06",{"date":78,"type":79},"2026-05-11","ACTUAL",{"date":81,"type":79},"2025-06-17",{"date":83,"type":64},"2026-07",{"name":5,"class":6},1]