[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Juan M Garcia-Gomez\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100601492",false,"NCT07111195","Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)","Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)","SINUE","Inclusion Criteria:\n\n* Adults (≥18 years old) at the time of diagnosis\n* Radiological diagnosis of high-grade glioma\n* Candidates for surgical resection\n* Availability of complete preoperative MRI studies, including:\n* T1-weighted MRI (pre- and post-gadolinium)\n* T2-weighted MRI\n* FLAIR (Fluid-Attenuated Inversion Recovery)\n* T2\\*-weighted DSC perfusion MRI\n* Signed informed consent to participate in the clinical study\n\nExclusion Criteria:\n\n* Patients who do not provide informed consent\n* Patients deemed inoperable\n\nWithdrawal criteria:\n\n* MRI data that cannot be processed using ONCOhabitats\n* Patient withdraws informed consent at any time","ALL","18 Years",{"count":19,"type":20},140,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma.\n\nThe study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support clinical decision-making.\n\nThe primary research questions are:\n\n* Can ONCOhabitats identify vascular and molecular characteristics within the peritumoral infiltrated edema (IPE) that are associated with patient prognosis?\n* Can these imaging biomarkers aid in stratifying patients according to their response to treatment, including temozolomide and immunotherapy?\n\nParticipants will:\n\n* Be adults diagnosed with high-grade glioma who are scheduled for surgical tumor resection\n* Undergo preoperative MRI processed with ONCOhabitats to segment the tumor into four biological habitats (HAT, LAT, IPE, and VPE)\n* Provide tissue samples from each habitat when feasible, based on surgical and clinical considerations\n\nResearchers will analyze:\n\n* Imaging biomarkers (e.g., relative cerebral blood volume, rCBV)\n* Molecular and histopathological features (e.g., MGMT promoter methylation, gene expression profiles associated with immunosuppression)\n* Clinical and survival outcomes\n\nThis study seeks to enhance glioblastoma characterization and support personalized treatment strategies through the clinical validation of a software platform.",[24],"Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype",[26,27,28,29,30,31,32,33,34,35,36,37,38],"Glioblastoma","IHD-wildtype","MRI","Biomarkers","Perfussion","Tumor heterogenity","Peritumoral edema","Tumor Infiltration","Machine learning","Medical device validation","Immunosuppression","Overall survival","MGMT status","RECRUITING","2025-07-31",{"date":42,"type":43},"2025-08-08","ACTUAL",{"date":45,"type":43},"2024-07-16",{"date":47,"type":20},"2026-09",{"name":49,"class":50},"Juan M Garcia-Gomez","OTHER",5,""]