[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553025":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":28,"locations":37,"responsibleParty":137,"collaborators":141,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":11,"enrollmentInfo":156,"targetDuration":11,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":173,"whyStopped":11,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clinical management is based on the index MRI and an additional [¹⁸F] FET-PET together","EXPERIMENTAL",null,[13],"Other: Clinical management based on the index MRI and an additional [¹⁸F] FET PET scan",{"label":15,"type":16,"description":11,"interventionNames":11},"Standard of care","NO_INTERVENTION",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"Clinical management based on the index MRI and an additional [¹⁸F] FET PET scan","Patients in the investigational arm will undergo the extra FET-PET scan, with use of the O-(2-\n\n¹⁸F-fluoroethyl)-L-tyrosine (¹⁸F-FET) tracer. FET-PET scanning will be performed according to the joint European Association of Nuclear Medicine (EANM)\u002FEuropean Association of Neuro-Oncology (EANO)\u002FResponse Assessment in Neuro-oncology (RANO) guidelines. In most patients, a static scan (20-40 minutes post-injection) will performed. If the logistics of the research site allow for a dynamic scan (0-60 minutes post-injection), this will be performed. Interpretation will be done by an experienced nuclear medicine physician from the local center according to current European guidelines. Central review will be performed by a panel of nuclear medicine physicians from the study team. Clinical management is based on the index MRI and this additional \\[¹⁸F\\] FET PET scan.",[9],[23,26],{"name":24,"affiliation":5,"role":25},"Tom J Snijders, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":5,"role":25},"Nelleke Tolboom, MD, PhD",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Veerle J Ruijters, MD","CONTACT","0031639656920","v.j.ruijters-6@umcutrecht.nl",{"name":27,"role":31,"phone":35,"phoneExt":11,"email":36},"003162878078","n.tolboom@umcutrecht.nl",[38,54,62,70,78,94,109,122],{"facility":39,"status":11,"city":40,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Amsterdam UMC","Amsterdam","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],4.88969,52.37403,{"lat":47,"lon":46},[50,53],{"name":51,"role":31,"phone":11,"phoneExt":11,"email":52},"Elsmarieke M van de Giessen, MD, PhD","E.m.vandegiessen@amsterdamumc.nl",{"name":51,"role":25,"phone":11,"phoneExt":11,"email":11},{"facility":55,"status":11,"city":56,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":11},"Medisch Spectrum Twente","Enschede",{"type":44,"coordinates":58},[59,60],6.89583,52.21833,{"lat":60,"lon":59},{"facility":63,"status":11,"city":64,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":65,"geoPoint":69,"contacts":11},"UMC Groningen","Groningen",{"type":44,"coordinates":66},[67,68],6.56667,53.21917,{"lat":68,"lon":67},{"facility":71,"status":11,"city":72,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":11},"Maastricht UMC","Maastricht",{"type":44,"coordinates":74},[75,76],5.68889,50.84833,{"lat":76,"lon":75},{"facility":79,"status":11,"city":80,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Radboud UMC","Nijmegen",{"type":44,"coordinates":82},[83,84],5.85278,51.8425,{"lat":84,"lon":83},[87,90,91],{"name":88,"role":31,"phone":11,"phoneExt":11,"email":89},"Dylan JH Henssen, MD, PhD","Dylan.Henssen@radboudumc.nl",{"name":88,"role":25,"phone":11,"phoneExt":11,"email":11},{"name":92,"role":93,"phone":11,"phoneExt":11,"email":11},"Anne I Arens, MD, PhD","SUB_INVESTIGATOR",{"facility":95,"status":11,"city":96,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Erasmus MC","Rotterdam",{"type":44,"coordinates":98},[99,100],4.47917,51.9225,{"lat":100,"lon":99},[103,106,107],{"name":104,"role":31,"phone":11,"phoneExt":11,"email":105},"Sophie EM Veldhuijzen van Zanten, MD, PhD","s.veldhuijzenvanzanten@erasmusmc.nl",{"name":104,"role":25,"phone":11,"phoneExt":11,"email":11},{"name":108,"role":93,"phone":11,"phoneExt":11,"email":11},"Marjolein Geurts, MD, PhD",{"facility":110,"status":11,"city":111,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Haaglanden MC","The Hague",{"type":44,"coordinates":113},[114,115],4.29861,52.07667,{"lat":115,"lon":114},[118,121],{"name":119,"role":31,"phone":11,"phoneExt":11,"email":120},"Maaike J Vos, MD, PhD","M.vos@haaglandenmc.nl",{"name":119,"role":25,"phone":11,"phoneExt":11,"email":11},{"facility":5,"status":11,"city":123,"state":11,"zip":124,"country":41,"countryCode":42,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Utrecht","3508 GA",{"type":44,"coordinates":126},[127,128],5.12222,52.09083,{"lat":128,"lon":127},[131,132,134,135,136],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},{"name":133,"role":31,"phone":35,"phoneExt":11,"email":36},"N Tolboom, MD, PhD",{"name":27,"role":25,"phone":11,"phoneExt":11,"email":11},{"name":24,"role":25,"phone":11,"phoneExt":11,"email":11},{"name":30,"role":93,"phone":11,"phoneExt":11,"email":11},{"type":138,"investigatorFullName":139,"investigatorTitle":140,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Veerle Ruijters","Medical researcher",[142,144],{"name":143,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":145,"class":146},"Curium PET France","INDUSTRY","100553025","fet-pet-guided-management-of-pseudoprogression-in-glioblastoma-100553025",false,"NCT06480721","FET-PET-Guided Management of Pseudoprogression in Glioblastoma","FET-POPPING","Inclusion Criteria:\n\n* Patients with a glioblastoma, IDH-wildtype, World Health Organization (WHO) grade 4, according to WHO 2021 criteria.\n* Age ≥18 years\n* New or increased enhancement within the high-dose radiation field (defined as within the 80% isodose line) on follow-up MRI\n* Follow up MRI ≥3 months after the end of the standard-of-care temozolomide-based concomitant chemoradiation (60 Gy\u002F30 fractions or 40 Gy\u002F15 fractions). Of note, very early increase - within 3 months of last radiation - will not be grounds for inclusion because of the high rate of pseudoprogression and slightly lower diagnostic performance of FET-PET compared to the situation of increase beyond 3 months after last radiation. Patients with such very early increase may have subsequent further increase after 3 months post-radiation, causing (further) diagnostic doubt; these may be included at that later timepoint if they meet the other inclusion criteria.\n* First moment of clinicoradiological uncertainty regarding the diagnosis (≥3 months after the end of chemoradiation): pseudoprogression or tumor recurrence. The determination of 'uncertainty' is made by the treating physician, preferably in the multidisciplinary tumor board, based on available clinical and standard-of-care MRI-data, which generally includes perfusion-MRI.\n* Previous usage of bevacizumab as a symptom treatment is allowed. However, inclusion is only allowed at the first moment of clinical doubt between pseudoprogression and tumor recurrence, not at later timepoints.\n\nExclusion Criteria:\n\n* Previous treatment for recurrence of disease\n* An enhanced lesion size of less than 1 cm on the index MRI. In the newest RANO PET criteria, it is advised to use FET-PET for increasing lesions only in cases with a minimum lesion size.\n* Life expectancy of less than 6 months, determined by the treating physician\n* Contra-indications for PET (claustrophobia, inability to lay still)\n* Women of childbearing potential without adequate contraception\n* Any other concomitant disease that may influence PET imaging or clinical outcomes of this study, this includes but is not limited to: cerebral inflammatory diseases and other cancers with brain- or leptomeningeal metastases","ALL","18 Years",{"count":157,"type":158},144,"ESTIMATED","INTERVENTIONAL",[161],"NA","The goal of this diagnostic randomised clinical trial is to determine, in glioblastoma patients with diagnostic uncertainty between pseudoprogression and tumor progression on follow-up MRI after chemoradiation, the added value of a direct \\[¹⁸F\\] FET-PET scan for clinical management.\n\nThe main questions it aims to answer are:\n\n* Does the clinical management guided by an additional FET-PET scan leads to fewer unnecessary interventions, compared with management based on MRI only?\n* Does the clinical management guided by an additional FET-PET scan leads to better health-related quality of life after 12 weeks, compared with management based on MRI only?\n* Does the clinical management guided by an additional FET-PET scan leads to reduced net healthcare costs, compared with management based on MRI only?\n\nResearchers will compare the investigational arm, where clinical management is based on the index MRI scan and an additional FET-PET scan, with the control arm, where clinical management is based solely on the index MRI scan, to investigate the added value of the FET PET scan for clinical management.\n\nParticipants in the investigational arm will undergo the FET PET scan. All participants will complete health-related quality of life questionnaires at four different timepoints.",[164,165],"Glioblastoma","Radionecrosis of Brain",[164,167,168,169,170,171,172],"[¹⁸F] FET PET","Tumor progression","Pseudoprogression","Unnecessary interventions","Health-related quality of life","Healthcare costs","NOT_YET_RECRUITING","2024-06-24",{"date":176,"type":177},"2024-06-28","ACTUAL",{"date":179,"type":158},"2024-08",{"date":181,"type":158},"2027-12",{"name":139,"class":6},8]