[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525308":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":105,"collaborators":109,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":35,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":35,"studyType":131,"phases":132,"briefSummary":135,"conditions":136,"keywords":141,"overallStatus":62,"whyStopped":35,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy controls (part 2)","EXPERIMENTAL","25 healthy subjects (5 young 20-40y and 20 between 50-85y) will be enrolled for the head-to-head comparison with \\[18F\\]-MFBG, \\[123I\\]-MIBG and \\[18F\\]-FE-PE2I (Part 2).\n\nIn 5 healthy controls, arterial sampling will be carried out for kinetic modelling.",[13,14,15],"Diagnostic Test: [18F]-MFBG PET CT","Diagnostic Test: [18F]-FE-PE2I PET CT or PET MRI","Diagnostic Test: [123I]-MIBG SPECT CT",{"label":17,"type":10,"description":18,"interventionNames":19},"PD vs MSA cohort (part 3a)","In total, 40 PD patients will be included. In order to determine relationships with disease progression, two subgroups will be included with disease duration up to 5 years and 5 years or more respectively. In total, 15 MSA-P patients will be enrolled. For both groups, abnormal previous \\[18F\\]-FE-PE2I or \\[123I\\]-FP-CIT SPECT scan is required.\n\nHead-to-head comparison with \\[18F\\]-MFBG, \\[123I\\]-MIBG and \\[18F\\]-FE-PE2I (Part 3).",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"AD vs DLB cohort (part 3b)","In total 15 patients with probable DLB (including biomarker selection through abnormal previous \\[18F\\]-FE-PE2I or \\[123I\\]-FP-CIT SPECT scan) and 15 patients with probable AD (including biomarker proven amyloid-beta positivity either by cerebrospinal fluid biomarker analysis or by \\[18F\\]-NAV4694 imaging as standard of care).\n\nHead-to-head comparison with \\[18F\\]-MFBG, \\[123I\\]-MIBG and \\[18F\\]-FE-PE2I (Part 3).",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Dosimetry in healthy controls (Part 1)","For dosimetry of \\[18F\\]-MFBG only, 3 subjects (18-80 y) will be enrolled (Part 1).",[28],"Diagnostic Test: [18F]-MFBG PET dosimetry scans",[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DIAGNOSTIC_TEST","[18F]-MFBG PET CT","\\[18F\\]-MFBG will be acquired at the Leuven University hospital on a GE MI4 PET\u002FCT camera, with low dose CT and 120 MBq injected activity. Dynamic imaging between 0-60 minutes and 100-120 minutes (patients) and 0-70 minutes and 90-120 minutes (healthy volunteers).\n\nVenous sampling between 5-120 minutes will be obtained through a second catheter, 6 venous samples will be taken.\n\nIn healthy up to 5 control subjects, full arterial sampling (0-120 minutes,) will also be done.\n\nIf patient comfort allows, after the dynamic cardiac scan 2 hours post-injection field dynamic scan, a fast late timepoint whole body PET\u002FCT will be taken (2 min\u002Fbed position, 11 mAs low dose CT; estimated 10-12 minutes).",[21,9,17],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"[18F]-FE-PE2I PET CT or PET MRI","\\[18F\\]-FE-PE2I will be performed at the University Hospital Leuven with the GE Signa simultaneous PET\u002FMR with acquisition at 50-70 minutes postinjection or at the University Hospital in Gent using a Siemens PET\u002FCT, GE MI4 PET\u002FCT.\n\nInjected activity: 120 MBq",[21,9,17],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"[123I]-MIBG SPECT CT","\\[123I\\]-MIBG SPECT\u002FCT (low dose CT) will be performed at the local nuclear medicine department of each participating center.\n\nInjected activity: 111 MBq",[21,9,17],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"[18F]-MFBG PET dosimetry scans","\\[18F\\]-MFBG will be acquired at the Leuven University hospital on a Siemens Truepoint or GE MI4 PET\u002FCT camera or equivalent newer camera, with low dose CT and 120 MBq injected activity.\n\nThree segments of consecutive whole-body scanning with increasing bed position duration will be carried out up to 3 half-lives (physical half-life T1\u002F2 for 18F = 110 minutes): from 0-90 minutes (scan 1-8), 120-150 (scan 9) and 300-330 (scan 10) minutes post injection. In total 10 whole body biodistribution scans will be taken. Urine will be collected and its total activity measured to measure bladder excretion for correction of integrated bladder organ residence. Before each segment, a low dose whole body CT scan (11 mAs) will be acquired for attenuation correction and organ delineation.",[25],[49],{"name":50,"affiliation":51,"role":52},"Koen Van Laere","Professor at KULeuven, department head of nuclear medicine at UZ Leuven","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},"Koen Van Laere, Prof. dr.","CONTACT","+3216343715","koen.vanlaere@UZLeuven.be",[60,85],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"UZ Ghent","RECRUITING","Ghent","Gent","9000","Belgium","BE",{"type":69,"coordinates":70},"Point",[71,72],3.71667,51.05,{"lat":72,"lon":71},[75,79,80,83],{"name":76,"role":56,"phone":77,"phoneExt":35,"email":78},"Donatienne Van Weehaeghe, Dr.","+32 9 332 30 27","donatienne.vanweehaeghe@uzgent.be",{"name":76,"role":52,"phone":35,"phoneExt":35,"email":35},{"name":81,"role":82,"phone":35,"phoneExt":35,"email":35},"Patrick Santens, Prof. dr.","SUB_INVESTIGATOR",{"name":84,"role":82,"phone":35,"phoneExt":35,"email":35},"Tim Van Langenhove, Dr.",{"facility":86,"status":62,"city":87,"state":88,"zip":89,"country":66,"countryCode":67,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"UZ Leuven","Leuven","Vlaams-Brabant","3000",{"type":69,"coordinates":91},[92,93],4.70093,50.87959,{"lat":93,"lon":92},[96,97,99,101,103],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},{"name":98,"role":52,"phone":35,"phoneExt":35,"email":35},"Koen Van Laere, Prof. Dr.",{"name":100,"role":82,"phone":35,"phoneExt":35,"email":35},"Wim Vandenberghe, Prof. Dr.",{"name":102,"role":82,"phone":35,"phoneExt":35,"email":35},"Aline Delva, Dr.",{"name":104,"role":82,"phone":35,"phoneExt":35,"email":35},"Louis Versweyveld, Dr.",{"type":106,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","prof. dr. Koen Van Laere","Head of Nuclear Medicine, professor, Principal Investigator",[110,112,114,116],{"name":111,"class":6},"University Hospital, Ghent",{"name":113,"class":6},"Fund for Scientific Research, Flanders, Belgium",{"name":115,"class":6},"KU Leuven",{"name":5,"class":6},"100525308","phase-2-18f-mfbg-versus-123i-mibg-and-18f-pe2i-in-pd-vs-msa-and-dlb-vs-ad-100525308",false,"NCT06120049","[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD","Prospective Head-to-head Comparison of Cardiac [18F]-MFBG PET Versus [123I]-MIBG SPECT in the Differentiation Between Parkinson's Disease and Multiple System Atrophy and Between Dementia With Lewy Bodies and Alzheimer's Disease","Inclusion Criteria:\n\n1. Healthy Controls:\n\n   * Voluntary written informed consent.\n   * Use of highly effective methods of birth control.\n   * Age between 18 and 85 years.\n   * Good health based on medical history, physical examination, clinical laboratory tests, and urinalysis.\n   * No history or evidence of major neurological, internal, or psychiatric disorders.\n   * Normal structural MRI scan for subjects \\\u003C 60 years or minor lesions for subjects \\>= 60 years.\n2. Parkinson's Disease:\n\n   * Age 45-85 years.\n   * Clinically established PD based on Movements Disorder Society diagnostic criteria.\n   * Disease duration since onset of motor symptoms: 5 years or longer for one group and less than 5 years for another.\n   * Previous abnormal \\[18F\\]-FE-PE2I PET or \\[123I\\]-FP-CIT SPECT scan.\n   * Ability to understand the patient information brochure and provide written informed consent.\n3. Multiple System Atrophy - Parkinsonian Variant:\n\n   * Age 45-85 years.\n   * Clinically established or clinically probable MSA-P based on MDS diagnostic criteria.\n   * Previous abnormal \\[18F\\]-FE-PE2I PET or \\[123I\\]-FP-CIT SPECT scan.\n   * Ability to understand the patient information brochure and provide written informed consent.\n4. Dementia Due to Alzheimer's Disease:\n\n   * Age 50-85 years.\n   * Diagnosis of probable AD with evidence of the AD pathophysiological process.\n   * Ability to understand the patient information brochure and provide written informed consent.\n5. Dementia with Lewy Bodies:\n\n   * Age 50-85 years.\n   * Diagnosis of probable DLB.\n   * Previous abnormal \\[18F\\]-FE-PE2I PET or \\[123I\\]-FP-CIT SPECT scan.\n   * Ability to understand the patient information brochure and provide written informed consent.\n\nExclusion Criteria:\n\n1. Healthy controls:\n\n   * Major diseases that may interfere with the investigations.\n   * Evidence of cognitive impairment.\n   * History or evidence of psychiatric disease.\n   * Use of illicit drugs or history of drug or alcohol abuse.\n   * Chronic medication interfering with cardiac neuronal norepinephrine transporter (NET) or \\[18F\\]-FE-PE2I imaging.\n   * Exposure to ionizing radiation \\> 1 mSv in other research studies within the last 12 months.\n   * Contraindication for MRI scanning.\n   * Claustrophobia or inability to tolerate confinement during PET-MRI scanning.\n   * Unwillingness to avoid strenuous physical activity.\n   * Lack of understanding of the study procedures.\n   * Pregnancy or breastfeeding.\n   * Lack of agreement to communicate incidental findings to the general practitioner.\n   * Abnormal Allen test or lidocaine hypersensitivity\u002Fallergy for subjects willing to undergo arterial sampling.\n2. Parkinson's Disease:\n\n   * Neuropsychiatric diseases other than PD.\n   * Major internal medical comorbidity, especially diabetes or heart disease.\n   * White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities.\n   * History of alcohol or drug abuse.\n   * Previous participation in research studies involving ionizing radiation.\n   * Contraindications for MR.\n   * Claustrophobia or inability to tolerate confinement during PET scanning.\n   * Unwillingness to avoid strenuous physical activity.\n   * Lack of understanding of the study procedures.\n   * Pregnancy or breastfeeding.\n   * Lack of agreement to communicate incidental findings to the general practitioner.\n   * Anticoagulant therapy.\n3. Multiple System Atrophy - Parkinsonian Variant:\n\n   * Same as for Parkinson's disease.\n4. Dementia Due to Alzheimer's Disease:\n\n   * Same as for Parkinson's disease.\n5. Dementia with Lewy Bodies:\n\n   * Same as for Parkinson's disease.",true,"ALL","18 Years","85 Years",{"count":129,"type":130},113,"ESTIMATED","INTERVENTIONAL",[133,134],"PHASE2","PHASE3","Study goal:\n\nThe goal of this prospective head to head comparison is to evaluate the effectiveness of \\[18F\\]-MFBG PET in assessing cardiac innervation, comparing it with \\[123I\\]-MIBG SPECT The study's primary focus is on distinguishing between Parkinson's disease (PD) and multiple system atrophy (MSA), as well as between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD).\n\nMain questions:\n\n* Feasibility: How well can \\[18F\\]-MFBG PET detect changes in myocardial uptake in PD and DLB compared to the expected normal values in healthy individuals and AD and MSA-P patients? How well can it differentiate between these groups based on the detected changes?\n* Non-inferiority: Is \\[18F\\]-MFBG PET as accurate as \\[123I\\]-MIBG SPECT in distinguishing between PD and MSA-P, and between DLB and AD?\n\nParticipant requirements:\n\nFor the main study, participants will be required to visit the hospital for 3 or 4 appointments. During these visits, they will undergo a screening visit, MRI brain scan, a comprehensive neurological assessment, \\[18F\\]-PE2I PET, \\[123I\\]-MIBG SPECT, and \\[18F\\]-MFBG PET scans.\n\nAdditionally, a separate dosimetry study will be conducted, involving healthy subjects who will visit the hospital for a screening visit and undergo \\[18F\\]-MFBG PET scans.",[137,138,139,140],"Parkinson Disease","Dementia With Lewy Bodies","MSA - Multiple System Atrophy","Alzheimer Disease",[137,142,139,140,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"Dementia with Lewy Bodies","[18F]-MFBG","[18F]-PE2I","[123I]-MIBG","Positron emission tomography","PET","Single photon emission tomography","SPECT","Autonomic dysfunction","Cardiac innervation","Brain DAT","Dosimetry","Kinetic modelling","Differential diagnosis","Dementia","Parkinsonism","Nuclear imaging","Neurology","Movement disorders","Prospective","2025-02-03",{"date":164,"type":165},"2025-02-06","ACTUAL",{"date":167,"type":165},"2024-01-19",{"date":169,"type":130},"2026-07",{"name":107,"class":6},2]