[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572963":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":39,"locations":47,"responsibleParty":87,"collaborators":89,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":25,"enrollmentInfo":104,"targetDuration":25,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Kuopio University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aspirate tissue monitoring","EXPERIMENTAL","In total fifty (n=50) patients referred for resection surgery for suspected high-grade glioma or its recurrence at the Kuopio University Hospital, Tampere University Hospital and Oslo University Hospital, and potential other trial sites, will be recruited to the study. The patients are prescribed oral 5-ALA preoperatively according to the institution's practices. The cases are operated with the help of aspirate tissue monitoring and the controls without. Other preferred adjunct techniques are used in both groups.",[13],"Device: Aspirate tissue monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Fluorescence-guided surgery","ACTIVE_COMPARATOR","The cases are compared with controls (n=50) from applicable local clinical site registers (matched controls).",[19],"Device: Fluorescence-guided surgery",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","This multicenter controlled clinical trial investigates the clinical performance and outcomes from using an aspirate tissue monitor (ATM, Marginum Ltd HIVEN™) that detects cancerous tissue from the suction waste during the surgical treatment of suspected high-grade gliomas. The ATM provides near real-time audible feedback to the surgeon when tumor-related fluorescence is detected in the aspirated tissues. The trial investigates if the use of ATM to detect 5-ALA induced fluorescence contributes to faster tumor removal, less blood loss, less unintended residual tumor, less morbidity, longer survival and the frequency of local reoperations. The cases are compared with controls (n=50) from applicable local clinical site registers (matched controls). The cases are operated with the help of aspirate tissue monitoring and the controls without. Other preferred adjunct techniques are used in both groups.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Resection utilizing conventional visual fluorescence-guided surgery.",[15],[30,33,36],{"name":31,"affiliation":5,"role":32},"Antti-Pekka Elomaa, Docent","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Joonas Haapasalo, Docent","Tampere University Hospital",{"name":37,"affiliation":38,"role":32},"Einar Vik-Mo, Professor","Oslo University Hospital",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":25,"email":44},"Sami Puustinen, PhD","CONTACT","+358442190767","sami.puustinen@marginum.com",{"name":31,"role":42,"phone":25,"phoneExt":25,"email":46},"antti-pekka.elomaa@pshyvinvointialue.fi",[48,63,74],{"facility":5,"status":49,"city":50,"state":51,"zip":25,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Kuopio","Northern Savonia","Finland","FI",{"type":55,"coordinates":56},"Point",[57,58],27.67703,62.89238,{"lat":58,"lon":57},[61],{"name":31,"role":42,"phone":25,"phoneExt":25,"email":62},"antti-pekka.elomaa@marginum.com",{"facility":35,"status":49,"city":64,"state":65,"zip":25,"country":52,"countryCode":53,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Tampere","Pirkanmaa",{"type":55,"coordinates":67},[68,69],23.78712,61.49911,{"lat":69,"lon":68},[72],{"name":34,"role":42,"phone":25,"phoneExt":25,"email":73},"joonas.haapasalo@pirha.fi",{"facility":38,"status":75,"city":76,"state":25,"zip":25,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"NOT_YET_RECRUITING","Oslo","Norway","NO",{"type":55,"coordinates":80},[81,82],10.74609,59.91273,{"lat":82,"lon":81},[85],{"name":37,"role":42,"phone":25,"phoneExt":25,"email":86},"uxvieb@ous-hf.no",{"type":88,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[90,91,92],{"name":35,"class":6},{"name":38,"class":6},{"name":93,"class":94},"Marginum Ltd.","INDUSTRY","100572963","feasibility-of-aspirate-tissue-monitoring-in-neuro-oncological-surgery-100572963",false,"NCT06740097","Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery","ATM GBM INT","Inclusion Criteria:\n\n* Patient admitted to neurosurgery department for surgical resection of a suspected high-grade glioma\n* Patients aged 18 years old or older\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled","ALL","18 Years",{"count":105,"type":106},50,"ESTIMATED","INTERVENTIONAL",[109],"NA","Gliomas are tumors that occur in all ages; they include the most common malign primary central nervous system tumors in developed countries. Gliomas are often aggressive, and their recommended treatment is surgical resection and chemoradiation. Complete tumor removal is challenging because of diffuse cell growth and the proximity of functionally critical tissues. Surgeons use 5-aminolevulinic acid (5-ALA) drug-induced fluorescence to visually detect tumor cells, which improves resection rates and delays tumor progression. Tumor cells are often left unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Surgical suction devices are used to remove cancerous tissues, but so far the suction aspirate tissues have not been routinely used in tissue detection. This multicenter controlled clinical trial investigates the clinical performance and outcomes of a new method for detecting tumor from the suction aspirates in near-real time based on 5-ALA induced fluorescence. The feedback from the aspirate tissue monitor (ATM) is expected to improve the identification of tumors, leading to fewer reoperations and better treatment outcomes.",[112],"High Grade Gliomas",[114,115,116,117,118],"aspirate tissue monitoring","high-grade glioma","5-ALA","fluorescence-guided surgery","neurosurgery","2024-12-13",{"date":121,"type":122},"2024-12-18","ACTUAL",{"date":124,"type":122},"2024-09-30",{"date":126,"type":106},"2028-09-01",{"name":5,"class":6},3]