[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lutroo Imaging LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Healthy Subjects",[29,30,31,32],"Radiocaine","PET imaging","medical imaging","diagnostic imaging","RECRUITING","2026-05-06",{"date":36,"type":37},"2026-05-11","ACTUAL",{"date":39,"type":37},"2025-06-17",{"date":41,"type":21},"2026-07",{"name":43,"class":44},"Lutroo Imaging LLC","INDUSTRY",""]