[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100392439":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":17,"armGroups":27,"interventions":37,"overallOfficials":48,"centralContacts":52,"locations":57,"responsibleParty":73,"collaborators":75,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":17,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":59,"whyStopped":17,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Brain Health Alliance","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Entire-body PET imaging of demyelination of peripheral and central nervous system","Exploratory analysis of relative regional increases and\u002For decreases of Amyvid activity","During 1 day single PET-CT scan",{"measure":14,"description":15,"timeFrame":16},"Psychometric questionnaire for monitoring psychological health","Assessments of participants","Up to 90 days",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"NON_RANDOMIZED","PARALLEL","Different PET-CT scanners (make and model) determine the different study arms for the intervention defined as a PET-CT medical imaging scan with the Amyvid imaging agent.","DIAGNOSTIC",{"masking":24,"maskingDescription":25,"whoMasked":17},"NONE","Participants will be de-identified; results will be anonymized.","To collect exploratory data using the most recent PET-CT scanners with their increased detection sensitivity and spatial resolution for the evaluation of F18-florbetapir radiopharmaceutical uptake in the nervous system of the entire body with special attention to correlation of radiotracer activity levels in the myelinated, demyelinated, or remyelinated white matter of multiple sclerosis (MS) patients compared to normal healthy subjects. The pilot study will be conducted on 20 participants as a clinical research trial of PET amyloid and myelin imaging with the primary objective of identifying possible differences in F18-florbetapir radiotracer activity for MS patients compared to normal healthy subjects, and the secondary objective of monitoring psychological health of those participants who elect to be informed of imaging results and who complete a panel of psychometric scales before and after imaging results disclosure.",[28,34],{"label":29,"type":6,"description":30,"interventionNames":31},"Siemens Biograph Vision PET-CT scans","Parallel study arms defined by PET-CT scanners by different manufacturer and model",[32,33],"Diagnostic Test: Entire-body PET-CT scans","Drug: Amyvid radiopharmaceutical",{"label":35,"type":6,"description":30,"interventionNames":36},"United Imaging uEXPLORER PET-CT scans",[32,33],[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":17},"DIAGNOSTIC_TEST","Entire-body PET-CT scans","Entire-body PET-CT scans will be performed with state-of-the-art scanners with different manufacturers' models including Siemens Biograph Vision, United Imaging uEXPLORER and possibly other recently FDA-approved PET-CT scanners.",[29,35],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":17},"DRUG","Amyvid radiopharmaceutical","Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants",[29,35],[49],{"name":50,"affiliation":5,"role":51},"Carl Taswell, MD, PhD","PRINCIPAL_INVESTIGATOR",[53],{"name":50,"role":54,"phone":55,"phoneExt":17,"email":56},"CONTACT","949-481-3121","ctaswell@brainhealthalliance.org",[58],{"facility":5,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Ladera Ranch","California","92694","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-117.63561,33.57086,{"lat":69,"lon":68},[72],{"name":50,"role":54,"phone":55,"phoneExt":17,"email":56},{"type":74,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[76,79],{"name":77,"class":78},"Center for Molecular Imaging & Therapy, Shreveport LA","UNKNOWN",{"name":80,"class":78},"Northern California PET Imaging Center, Sacramento CA","100392439","early-phase-1-entire-body-pet-scans-for-multiple-sclerosis-100392439",false,"NCT04390009","Entire-body PET Scans for Multiple Sclerosis","Exploratory Study of Entire-body PET Scans for Multiple Sclerosis","EPSMS","Inclusion Criteria:\n\n* Multiple sclerosis (MS) patients diagnosed by a credentialed neurologist experienced with care of multiple sclerosis patients.\n* Normal healthy subjects.\n* Willing and able to lie motionless on the PET-CT scanner bed for at least 10 minutes and up to 20 minutes for the duration of the PET-CT medical imaging scan.\n\nExclusion Criteria:\n\n* Any additional complicating medical illness other than MS including any other neuropsychiatric illness unrelated to MS diagnosed prior to the onset of initial symptoms of MS.\n* Pregnancy or breast feeding.\n* Diabetes or other metabolic-endocrine disorders.\n* Any known concomitant acute infection.\n* History of metastatic or locally invasive cancer.\n* Recent surgery, chemotherapy or radiation therapy.",true,"ALL","25 Years","55 Years",{"count":94,"type":95},20,"ESTIMATED","INTERVENTIONAL",[98],"EARLY_PHASE1","To evaluate whether an entire-body positron emission tomography (PET) scanner can be exploited to improve evaluation, monitoring and measurement of both peripheral and central demyelination in multiple sclerosis (MS) patients.",[101],"Multiple Sclerosis",[101,103],"Entire-body PET imaging","2026-10-02",{"date":106,"type":107},"2026-10-06","ACTUAL",{"date":109,"type":107},"2024-09-30",{"date":111,"type":95},"2028-06-30",{"name":5,"class":6},1]