[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525206":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":159,"collaborators":163,"id":176,"slug":177,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":178,"sex":184,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":10,"studyType":190,"phases":10,"briefSummary":191,"conditions":192,"keywords":205,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Supramaximal resection",null,"Supramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy)",[13],"Procedure: Supramaximal resection",{"label":15,"type":10,"description":16,"interventionNames":17},"Maximal safe resection","Maximal safe resection of the contrast-enhancing part of the tumor",[18],"Procedure: Maximal safe resection",[20,28],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Supramaximal resection. Tumor resection continues until either the FLAIR abnormalities have been resected based on the neuronavigation (after updating the navigation intraoperatively), or when subcortical tracts are identified with intraoperative stimulation.",[9],[25,26,27],"Supramarginal resection","FLAIRectomy","Resection of the non-contrast-enhancing tumor",{"type":21,"name":15,"description":29,"armGroupLabels":30,"otherNames":10},"Maximal safe resection. Tumor resection continues until maximal safe resection has been achieved as by the neurosurgeon's opinion.",[15],[32],{"name":33,"affiliation":5,"role":34},"Jasper Gerritsen, MD PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":10,"email":39},"CONTACT","+31107036130","j.gerritsen@erasmusmc.nl",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Arnaud Vincent, MD PhD","+31107034211","a.vincent@erasmusmc.nl",[45,62,75,89,106,120,133,145],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of California, San Francisco (UCSF)","RECRUITING","San Francisco","California","94143","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-122.41942,37.77493,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":10,"phoneExt":10,"email":10},"Mitchel Berger, MD",{"facility":63,"status":47,"city":64,"state":65,"zip":66,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":54,"coordinates":68},[69,70],-71.05977,42.35843,{"lat":70,"lon":69},[73],{"name":74,"role":37,"phone":10,"phoneExt":10,"email":10},"Brian Nahed, MD",{"facility":76,"status":47,"city":77,"state":10,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University Hospitals Leuven","Leuven","3000","Belgium","BE",{"type":54,"coordinates":82},[83,84],4.70093,50.87959,{"lat":84,"lon":83},[87],{"name":88,"role":37,"phone":10,"phoneExt":10,"email":10},"Steven De Vleeschouwer, MD PhD",{"facility":90,"status":47,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Universitätsklinikum Heidelberg","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":54,"coordinates":97},[98,99],8.69079,49.40768,{"lat":99,"lon":98},[102,104],{"name":103,"role":37,"phone":10,"phoneExt":10,"email":10},"Christine Jungk, MD PhD",{"name":105,"role":37,"phone":10,"phoneExt":10,"email":10},"Sandro Krieg, MD MBA",{"facility":107,"status":108,"city":109,"state":110,"zip":111,"country":94,"countryCode":95,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Technical University Munich","NOT_YET_RECRUITING","Munich","Bavaria","74076",{"type":54,"coordinates":113},[114,115],11.57549,48.13743,{"lat":115,"lon":114},[118],{"name":119,"role":37,"phone":10,"phoneExt":10,"email":10},"Arthur Wagner, MD PhD",{"facility":5,"status":47,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":54,"coordinates":127},[128,129],4.47917,51.9225,{"lat":129,"lon":128},[132],{"name":33,"role":37,"phone":10,"phoneExt":10,"email":10},{"facility":134,"status":47,"city":135,"state":122,"zip":136,"country":124,"countryCode":125,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Haaglanden Medical Centre","The Hague","2512 VA",{"type":54,"coordinates":138},[139,140],4.29861,52.07667,{"lat":140,"lon":139},[143],{"name":144,"role":37,"phone":10,"phoneExt":10,"email":10},"Marike Broekman, MD PhD",{"facility":146,"status":108,"city":147,"state":10,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Inselspital Universitätsspital Bern","Bern","3010","Switzerland","CH",{"type":54,"coordinates":152},[153,154],7.44744,46.94809,{"lat":154,"lon":153},[157],{"name":158,"role":37,"phone":10,"phoneExt":10,"email":10},"Philippe Schucht, MD PhD",{"type":160,"investigatorFullName":161,"investigatorTitle":162,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Jasper Gerritsen","Dr.",[164,165,167,169,171,173,174],{"name":134,"class":6},{"name":166,"class":6},"Universitaire Ziekenhuizen KU Leuven",{"name":168,"class":6},"University Hospital Heidelberg",{"name":170,"class":6},"Technical University of Munich",{"name":172,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":63,"class":6},{"name":175,"class":6},"University of California, San Francisco","100525206","the-supramax-study-supramaximal-resection-versus-maximal-resection-for-high-grade-glioma-patients-encram-2201-100525206",false,"NCT06118723","The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","SUPRAMAX","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Multifocal contrast enhancing lesions\n3. Medical reasons precluding MRI (e.g. pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin","ALL","18 Years","90 Years",{"count":188,"type":189},784,"ESTIMATED","OBSERVATIONAL","A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[193,194,195,196,197,198,199,200,201,202,203,204],"Glioblastoma","High-grade Glioma","Glioblastoma, IDH-wildtype","Glioblastoma, IDH-mutant","Glioblastoma Multiforme, Adult","Astrocytoma, Grade IV","Astrocytoma, Grade III","Astrocytoma, Malignant","Brain Neoplasms","Brain Neoplasm, Primary","Brain Neoplasms, Adult","Brain Neoplasm, Malignant",[193,9,26,206,207,208,209,210],"Non-contrast enhancement","Neurological morbidity","Quality of life","Overall survival","Progression-free survival","2024-02-20",{"date":213,"type":214},"2024-02-22","ACTUAL",{"date":216,"type":214},"2022-01-01",{"date":218,"type":189},"2028-01-01",{"name":161,"class":6},8]