[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05805839":3,"trial-entities:NCT05805839":100,"trial-summary:NCT05805839":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":50,"secondary_outcomes":58,"sex":63,"minimum_age":64,"maximum_age":17,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":77,"locations":80,"central_contacts":90,"overall_officials":91,"references":95,"see_also_links":96},"NCT05805839","22-009149","A Study of Imaging in Demyelinating Diseases","Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System","ENROLLING_BY_INVITATION","2028-05","2025-08","2025-08-29","2023-07-10","Mayo Clinic","OTHER",false,"This purpose of this study is research the usefulness of MRI with PET\u002FCT imaging for measuring brain inflammation and its relation to Multiple Sclerosis (MS).",null,[19,20],"Multiple Sclerosis","Inflammatory Demyelinating Disease",[],"INTERVENTIONAL","DIAGNOSTIC",[25],"PHASE2",{"count":27,"type":28},200,"ESTIMATED",[30,37,41,46],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","C-11 ER176 Radiotracer","Administered at a single time IV prior to the PET imaging. The injected dose of C-11 ER176 will be 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi).",[35,36],"Healthy Control Group","Multiple Sclerosis Group",{"type":31,"name":38,"description":39,"armGroupLabels":40},"C11 Pittsburgh Compound B","Administered at a single time IV prior to the PET imaging. The injected dose of C-11 PiB will be 555 MBq (range 370 - 629 MBq).",[35,36],{"type":42,"name":43,"description":44,"armGroupLabels":45},"DIAGNOSTIC_TEST","PET\u002FCT scan","Imaging of entire brain",[35,36],{"type":42,"name":47,"description":48,"armGroupLabels":49},"MRI","Magnetic Resonance Imaging of the Brain",[35,36],[51,55],{"measure":52,"description":53,"timeFrame":54},"Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin","C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr)","Baseline",{"measure":56,"description":57,"timeFrame":54},"Uptake of C-11 ER176 Radiotracer","C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr",[59],{"measure":60,"description":61,"timeFrame":62},"Number of subjects with adverse events","Total number of subjects to experience adverse events","2 days","ALL","18 Years",true,{"inclusion":67,"exclusion":72,"raw_text":76},[68,69,70,71],"Meet the requirements for one of the case or control groups.","MS patients undergoing neurologic evaluation procedures as part of Understanding Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders (IRB# 19-002807) Study or the Mayo Clinic Neurology Multiple Sclerosis Clinic.","Control participants without inflammatory-demyelinating diseases of the central nervous system","Capacity to sign consent.",[73,74,75],"Participants unable to lie down without moving for 20 minutes.","Women who are pregnant or cannot stop breast feeding for 24 hours.","For all patients and controls, any acute glucocorticoid (e.g., IV methylprednisolone or PO prednisolone) use within 2 weeks is an exclusion to limit medication interaction but preserve possible chronic systemic inflammation interaction with microglia activation metrics. Chronic disease modifying treatments in MS are allowed as these medications are not known to impact microglia activation.","Inclusion Criteria:\n\n* Meet the requirements for one of the case or control groups.\n* MS patients undergoing neurologic evaluation procedures as part of Understanding Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders (IRB# 19-002807) Study or the Mayo Clinic Neurology Multiple Sclerosis Clinic.\n* Control participants without inflammatory-demyelinating diseases of the central nervous system\n* Capacity to sign consent.\n\nExclusion Criteria:\n\n* Participants unable to lie down without moving for 20 minutes.\n* Women who are pregnant or cannot stop breast feeding for 24 hours.\n* For all patients and controls, any acute glucocorticoid (e.g., IV methylprednisolone or PO prednisolone) use within 2 weeks is an exclusion to limit medication interaction but preserve possible chronic systemic inflammation interaction with microglia activation metrics. Chronic disease modifying treatments in MS are allowed as these medications are not known to impact microglia activation.\n* Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc., since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his\u002Fher MRI.",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Mayo Clinic Minnesota","Rochester","Minnesota","55905","United States",{"lat":88,"lon":89},44.02163,-92.4699,[],[92],{"name":93,"affiliation":13,"role":94},"Burcu Zeydan, MD","PRINCIPAL_INVESTIGATOR",[],[97],{"label":98,"url":99},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":101,"biomarkers":102},[20,19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]