Nctid:
NCT06226519
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012008", "term"=>"Recurrence"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "asFound"=>"Recurrence", "relevance"=>"HIGH"}, {"id"=>"M5209", "name"=>"Brain Neoplasms", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T852", "name"=>"Brain Tumor, Childhood", "asFound"=>"Pediatric Brain Tumor", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000086242", "term"=>"Carbon-11 methionine"}], "ancestors"=>[{"id"=>"D000019275", "term"=>"Radiopharmaceuticals"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M55222", "name"=>"Carbon-11 methionine", "asFound"=>"CAP-1002", "relevance"=>"HIGH"}, {"id"=>"M21258", "name"=>"Radiopharmaceuticals", "relevance"=>"LOW"}, {"id"=>"T12", "name"=>"Methionine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Amino Acids", "abbrev"=>"AA"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2020-05-13", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-05-13", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-04", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-13", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"MET-PET/brain MRI in children with brain tumor for diagnosis of brain tumor recurrence compared to therapy-induced changes.", "timeFrame"=>"4 years", "description"=>"The role of MET-PET/MRI and radiogenomics could play in the follow-up management of children and adolescents with brain tumors and in ensuring timely intervention in case of tumor recurrence/progression."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pediatric Brain Tumor"]}, "descriptionModule"=>{"briefSummary"=>"Nuclear magnetic resonance imaging (NMR) is used in pediatric brain tumors for purposes of diagnosis, evaluation of response to treatments, and monitoring of patients in follow-up. Through conventional imaging techniques it remains difficult to differentiate tumor recurrence from pseudo-progression or other iatrogenic changes after radiotherapy or chemotherapy, but it remains a relevant and essential clinical need for patient management."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"60 children and/or adolescents (≤18 years) with a diagnosis of brain tumor (medulloblastoma, other embryonal tumors or high-grade gliomas), who have followed the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy and completed radiotherapy for at at least 6 months will undergo a brain MET-PET/MRI.", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* children and/or adolescents (≤18 years) diagnosed with brain tumor.\n* children who underwent the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy.\n\nExclusion Criteria:\n\n* patients \\>18 years"}, "identificationModule"=>{"nctId"=>"NCT06226519", "briefTitle"=>"Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children", "organization"=>{"class"=>"OTHER", "fullName"=>"IRCCS San Raffaele"}, "officialTitle"=>"Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children", "orgStudyIdInfo"=>{"id"=>"PET/RMN"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"11C-MET-PET/RMN", "type"=>"DIAGNOSTIC_TEST", "description"=>"60 children and/or adolescents (≤18 years) with a diagnosis of brain tumor (medulloblastoma, other embryonal tumors or high-grade gliomas), who have followed the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy and completed radiotherapy for at least 6 months will undergo a brain MET-PET/MRI."}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Milano", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Arturo Chiti", "role"=>"CONTACT", "email"=>"chiti.arturo@hsr.it", "phone"=>"0226432716"}, {"name"=>"Alessandra Maielli", "role"=>"CONTACT", "email"=>"maielli.alessandra@hsr.it", "phone"=>"0226433639"}], "facility"=>"Irccs San Raffaele", "geoPoint"=>{"lat"=>45.46427, "lon"=>9.18951}}], "centralContacts"=>[{"name"=>"Arturo Chiti", "role"=>"CONTACT", "email"=>"chiti.arturo@hsr.it", "phone"=>"0226432716"}, {"name"=>"Alessandra Maielli", "role"=>"CONTACT", "email"=>"maielli.alessandra@hsr.it", "phone"=>"0226433639"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"IRCCS San Raffaele", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele", "investigatorFullName"=>"Chiti Arturo", "investigatorAffiliation"=>"IRCCS San Raffaele"}}}}
