[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100368775":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":23,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":23,"overallStatus":36,"whyStopped":23,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Meningioma","Cohort of 30 subjects with meningioma.",[12],"Diagnostic Test: Ga68-DOTATATE-PET\u002FMRI",{"label":14,"type":6,"description":15,"interventionNames":16},"Non-Meningioma","Cohort of 60 subjects with non-meningioma:\n\n(esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma and SSTR-positive tumors metastatic to the brain)",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","Ga68-DOTATATE-PET\u002FMRI","In patients with meningioma who are undergoing surgical planning, subjects will undergo a PET scan at the time of their pretreatment or preoperative standard of care MRI exam, prior to surgery performed for research purposes. Instead of the standard of care MRI exam, subjects will undergo a dedicated hybrid Gallium-68-DOTATATE PET\u002FMRI.There will be up to two follow-up with Ga68-DOTATATE PET\u002FMRI scans performed as standard of care.\n\nIn patients with SSTR-positive CNS tumors that are non-meningioma, MRI is often performed to assess extent of disease. Subjects may be asked to undergo a PET scan for research purposes at the time of their standard of care MRI. Instead of the standard of care MRI exam, they may be asked to undergo a dedicated hybrid Gallium-68-DOTATATE PET\u002FMRI.",[9,14],null,[25],{"name":26,"affiliation":5,"role":27},"Jana Ivanidze, MD\u002FPh.D","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":23,"email":32},"CONTACT","212-746-4587","jai9018@med.cornell.edu",[34],{"facility":35,"status":36,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Weill Cornell Medicine","RECRUITING","New York","10065","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-74.00597,40.71427,{"lat":45,"lon":44},[48],{"name":26,"role":30,"phone":31,"phoneExt":23,"email":32},{"type":50,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[52],{"name":53,"class":54},"Novartis Pharmaceuticals","INDUSTRY","100368775","phase-4-68-ga-dotatate-petmri-in-the-diagnosis-and-management-of-somatostatin-receptor-positive-cns-tumors-100368775",false,"NCT04081701","68-Ga DOTATATE PET\u002FMRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.","68Ga(Gallium)-DOTATATE Positron Emission Tomography (PET)\u002FMRI in the Diagnosis and Management of Somatostatin Receptor Positive Central Nervous System CNS Tumors.","DOMINO-START","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Diagnosis of meningioma based on pathology reports and suspected recurrence or residual disease based on standard-of-care MRI\n* Additionally, patients with other somatostatin receptor 2 positive brain tumors, including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain will be considered for the purposes of obtaining feasibility data\n* As the investigator's institution, PET\u002FMRI scanner utilizes a 3 Tesla (T) magnet, patients who may be ineligible to undergo 3T MRI but may undergo 1.5 Tesla (T) MRI, will undergo a 1.5T MRI as per clinical standard-of-care and a Ga68-DOTATATE PET\u002FCT with the PET portion to be fused with the 1.5T MRI utilizing fusion software.\n\nExclusion Criteria:\n\n* Contraindications to gadolinium-based contrast agent\n* History of allergic reaction to Gallium-68-DOTATATE\n* Pregnancy","ALL","18 Years","100 Years",{"count":67,"type":68},200,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","The study population consists of patients who undergo resection for somatostatin receptor-positive (SSTR-positive) CNS tumors, focusing on meningioma, and including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain, such as small cell carcinoma of the lung. The study indication is to determine the diagnostic utility of 68Ga-DOTATATE PET\u002FMRI in the diagnosis and management of patients with SSTR-positive CNS tumors, specifically whether 68Ga-DOTATATE PET\u002FMRI demonstrates utility distinguishing between tumor recurrence and post-treatment change. To date, the utility of Ga-68-DOTATATE PET\u002FMRI in meningioma has not been explored. Investigators have over the past 3 months been able to accrue the largest case series of presently 12 patients in whom Ga-68-DOTATATE PET\u002FMRI demonstrated utility in the assessment of meningioma, including assessment for postsurgical\u002Fpostradiation recurrence, detection of additional lesions not visualized on MRI alone, and evaluation of osseous invasion. Based on this initial experience, investigators intend to study the impact of Ga-68-DOTATATE PET\u002FMRI in the assessment of the extent of residual tumor in patients status post meningioma resection, specifically in patients in whom tumor location limits resectability, patients with World Health Organization (WHO) grade II\u002FIII disease, and patients with history of stereotactic radiosurgery (SRS) who develop postradiation change.",[74,9,75,76,77,78,79],"CNS Tumors","Esthesioneuroblastoma","Hemangioblastoma","Medulloblastoma","Paraganglioma","Pituitary Adenoma","2025-11-17",{"date":82,"type":83},"2025-11-21","ACTUAL",{"date":85,"type":83},"2019-09-04",{"date":87,"type":68},"2038-12-31",{"name":5,"class":6},1]