Nctid:
NCT06221644
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000019578", "term"=>"Multiple System Atrophy"}, {"id"=>"D000012791", "term"=>"Shy-Drager Syndrome"}], "ancestors"=>[{"id"=>"D000054969", "term"=>"Primary Dysautonomias"}, {"id"=>"D000001342", "term"=>"Autonomic Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000001480", "term"=>"Basal Ganglia Diseases"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009069", "term"=>"Movement Disorders"}, {"id"=>"D000080874", "term"=>"Synucleinopathies"}, {"id"=>"D000019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D000007022", "term"=>"Hypotension"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M4589", "name"=>"Atrophy", "relevance"=>"LOW"}, {"id"=>"M21514", "name"=>"Multiple System Atrophy", "asFound"=>"Multiple System Atrophy", "relevance"=>"HIGH"}, {"id"=>"M15597", "name"=>"Shy-Drager Syndrome", "asFound"=>"Multiple System Atrophy", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M4643", "name"=>"Autonomic Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M27979", "name"=>"Primary Dysautonomias", "relevance"=>"LOW"}, {"id"=>"M25603", "name"=>"Ganglion Cysts", "relevance"=>"LOW"}, {"id"=>"M16358", "name"=>"Synovial Cyst", "relevance"=>"LOW"}, {"id"=>"M4774", "name"=>"Basal Ganglia Diseases", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12029", "name"=>"Movement Disorders", "relevance"=>"LOW"}, {"id"=>"M2217", "name"=>"Synucleinopathies", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}, {"id"=>"M10072", "name"=>"Hypotension", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"T3956", "name"=>"Multiple System Atrophy", "asFound"=>"Multiple System Atrophy", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>90}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-04-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2022-11-25", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-10-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Spatial synaptic density alterations in MSA patients", "timeFrame"=>"10 months", "description"=>"To examine spatial synaptic density alterations in MSA patients"}, {"measure"=>"[18F]SynVesT-1 PET as an imaging biomarker for MSA", "timeFrame"=>"10 months", "description"=>"evaluate the potential of \\[18F\\]SynVesT-1 PET as an imaging biomarker for MSA"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["synaptic density; PET; SV2A"], "conditions"=>["Multiple System Atrophy"]}, "descriptionModule"=>{"briefSummary"=>"Synaptic loss has been implicated in various neurodegenerative conditions, yet its understanding in multiple system atrophy (MSA) remains limited.\n\nThe aim of this study was to examine spatial synaptic density alterations in MSA patients and evaluate the potential of \\[18F\\]SynVesT-1 PET as an imaging biomarker for MSA in both diagnosis and monitoring disease severity.", "detailedDescription"=>"60 MSA patients (30 MSA-P subtype and 30 MSA-C subtype) and 30 age-matched healthy controls (HCs) underwent \\[18F\\]SynVesT-1 PET/CT for synaptic density assessment. Visual, voxel, and volumetric region-of-interest (VOI) analyses were employed to elucidate synaptic density patterns in the MSA brain and establish visual diagnostic criteria. VOI-based computer-assisted analyses were utilized to develop diagnostic models for MSA."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"60 patients diagnosed with MSA were recruited. The patient cohort consisted of 30 MSA-C and 30 MSA-P cases, diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists. Additionally, 30 gender and age-matched HCs were included.", "eligibilityCriteria"=>"Inclusion Criteria:\n\nThe MSA patient were diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists.\n\nExclusion Criteria:\n\nencompassed MRI contraindications, a history of epilepsy, stroke, or brain surgery, intracranial organic lesions unrelated to MSA, usage of levetiracetam or brivaracetam, and a history of alcohol or drug abuse"}, "identificationModule"=>{"nctId"=>"NCT06221644", "briefTitle"=>"Synapse Alterations in MSA Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Xiangya Hospital of Central South University"}, "officialTitle"=>"Synapse Alterations in MSA Patients", "orgStudyIdInfo"=>{"id"=>"20240113"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"MSA patients group", "description"=>"The patient cohort consisted of 30 MSA-C and 30 MSA-P cases, diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists", "interventionNames"=>["Diagnostic Test: [18F]SynVesT-1 PET/CT"]}, {"label"=>"healthy controls (HCs) group", "description"=>"30 gender and age-matched HCs were included", "interventionNames"=>["Diagnostic Test: [18F]SynVesT-1 PET/CT"]}], "interventions"=>[{"name"=>"[18F]SynVesT-1 PET/CT", "type"=>"DIAGNOSTIC_TEST", "description"=>"60 MSA patients (30 MSA-P subtype and 30 MSA-C subtype) and 30 age-matched healthy controls (HCs) underwent \\[18F\\]SynVesT-1 PET/CT for synaptic density assessment", "armGroupLabels"=>["MSA patients group", "healthy controls (HCs) group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"410008", "city"=>"Changsha", "state"=>"Hunan", "country"=>"China", "facility"=>"Jian Li", "geoPoint"=>{"lat"=>28.19874, "lon"=>112.97087}}], "overallOfficials"=>[{"name"=>"Shuo Hu", "role"=>"STUDY_CHAIR", "affiliation"=>"Shuo Hu"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Xiangya Hospital of Central South University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
