[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100606494","phase-2-18f-mfbg-cardiac-uptake-with-lewy-body-dementia-100606494",false,"NCT07176286","18F-mFBG Cardiac Uptake With Lewy Body Dementia","An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With and Without Lewy Body Diseases","IRP101-231","Inclusion Criteria:\n\n* 1\\. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.\n\n  3\\. A male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and\u002For hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative.\n\n  4\\. All subjects: Judged clinically stable for at least 30 days before enrolment into the study and remains stable to the time of the study imaging procedure.\n\nFor Lewy body disease subjects (Study Cohort I):\n\n5\\. The subject has a diagnosis of either PD or DLB based on accepted clinical criteria at least 6 months before enrollment into the study.\n\nFor non-Lewy body disease subjects (Study Cohort II):\n\n6\\. The subject has a diagnosis of neurological or neurodegenerative disease for which neither PD nor DLB is judged likely by a neurologist based on accepted clinical and imaging criteria.\n\nExclusion Criteria:\n\n* 1\\. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.\n\n  2\\. History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.\n\n  3\\. Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.\n\n  4\\. Documented ischemic heart disease (prior myocardial infarction, unstable angina, etc) or a diagnosis of heart failure of ischemic or non-ischemic etiology.\n\n  5\\. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.\n\n  6\\. The subject is claustrophobic or has a movement disorder that prevents him\u002Fher from lying still in a supine position for up to 20 minutes.\n\n  7\\. Renal insufficiency (serum creatinine \\>3.0 mg\u002FdL). 8. Uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.\n\n  9\\. Participated in a research study using ionizing radiation in the previous 12 months such that participation in the study might result in a total effective dose from research procedures exceeding 50 milliSieverts during that time interval.","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.",[27,28],"Parkinson Disease (PD)","Lewy Body Dementia (LBD)",[15,30],"18F-mFBG","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2026-04-30",{"date":39,"type":21},"2026-12-30",{"name":41,"class":42},"Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":43},"100590300","phase-2-18f-mfbg-imaging-for-myocardial-sympathetic-innervation-100590300","NCT06965621","18F-mFBG Imaging for Myocardial Sympathetic Innervation","An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With Heart Failure and Implantable Cardioverter-Defibrillators","Inclusion Criteria:\n\n* Stable heart failure from ischemic cardiomyopathy, LVEF \\\u003C or = 35%, ICD implantation for at least 12 months\n\nExclusion Criteria:\n\n* Unstable coronary artery disease, no ICD implantation",{"count":20,"type":21},[24],"This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to:\n\n* document the degree to which 18F-mFBG uptake in the heart is reduced (compared to historical controls)\n* characterize the distribution of regional abnormalities in relation to findings on rest\u002Fstress positron-emission tomography (PET) myocardial perfusion imaging (MPI)\n* determine if there are global and\u002For regional differences in myocardial sympathetic innervation between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).\n\nSafety data will be collected to identify adverse events \\[AEs\\] and serious adverse events \\[SAEs\\] and characterize the safety profile of 18F-mFBG.",[55,56,57],"Heart Failure","Ischemic Cardiomyopathy","ICD Patients",[59,60,30],"Myocardial sympathetic innervation","PET myocardial imaging",{"date":34,"type":35},{"date":63,"type":35},"2025-11-05",{"date":39,"type":21},{"name":41,"class":42},""]