[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475718":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":54,"collaborators":26,"id":57,"slug":26,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Sklifosovsky Institute of Emergency Care","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fluorescence and Ultrasound","EXPERIMENTAL","Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography",[13],"Device: Combined ultrasound and fluorescence-guided brain tumor resection",{"label":15,"type":16,"description":17,"interventionNames":18},"Fluorescence","ACTIVE_COMPARATOR","Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid",[19],"Device: Fluorescence-guided brain tumor resection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Combined ultrasound and fluorescence-guided brain tumor resection","Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Fluorescence-guided brain tumor resection","Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope",[15],[32],{"name":33,"affiliation":5,"role":34},"Alexander Dmitriev, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+7 (916) 423-54-08","dmitriev@neurosklif.ru",[41],{"facility":5,"status":42,"city":43,"state":26,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Moscow","129090","Russia",{"type":47,"coordinates":48},"Point",[49,50],37.61781,55.75204,{"lat":50,"lon":49},[53],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":34,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Alexander Dmitriev","Neurosurgeon, MD","100475718",false,"NCT05474573","Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases","Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial","CONFLUENSE","Inclusion Criteria:\n\n* single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)\n* one or several brain metastases from any cancer\n* newly diagnosed\n* Karnofsky Performance Status 60-100%\n* age 18-79 years\n* performed magnetic resonance imaging with contrast enhancement\n\nExclusion Criteria:\n\n* tumor spreading to corpus callosum or brainstem\n* previously performed brain radiotherapy\n* planned supratotal tumor resection until neurophysiologically revealed eloquent areas\n* known hypersensibility to 5-aminolevulinic or to porphyrin\n* hepatic or renal insufficiency\n* porphyria\n* pregnancy\n* breast feeding","ALL","18 Years","79 Years",{"count":68,"type":69},52,"ESTIMATED","INTERVENTIONAL",[72],"NA","Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.",[75,76],"Glioma, Malignant","Metastases to Brain",[78,79,80,81,82,83,84],"contrast-enhancing glioma","brain metastasis","sonography","ultrasound","fluorescence","5-aminolevulinic acid","5-ALA","2025-05-13",{"date":87,"type":88},"2025-05-16","ACTUAL",{"date":90,"type":88},"2022-09-01",{"date":92,"type":69},"2027-08-31",{"name":5,"class":6},1]