[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601492":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":95,"collaborators":99,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":10,"enrollmentInfo":119,"targetDuration":10,"studyType":122,"phases":10,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Universitat Politècnica de València","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with IDH-wildtype Glioblastoma",null,"Patients with IDH-wildtype glioblastoma who have undergone a pre-surgical MRI study",[13],"Device: The ONCOhabitats software for MRI-based habitat segmentation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","The ONCOhabitats software for MRI-based habitat segmentation","ONCOhabitats is an MRI-based software platform designed to segment IDH-wildtype glioblastomas into four biologically distinct habitats (HAT, LAT, IPE, and VPE) based on vascular heterogeneity.\n\nIn this study, the software is applied preoperatively to generate imaging biomarkers that guide surgical sampling and are assessed for their ability to predict overall survival and stratify patients accordingly.\n\nThe intervention includes advanced perfusion imaging processing using the HTS methodology, non-invasive tumor characterization, and integration with molecular and histopathological data.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Juan Miguel García Gómez, PhD, Full Professor","CONTACT","+34 963877069","juanmig@upv.es",[27,44,56,69,82],{"facility":28,"status":29,"city":30,"state":10,"zip":10,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Hospital General Universitario Dr. Balmis","RECRUITING","Alicante","Spain","ES",{"type":34,"coordinates":35},"Point",[36,37],-0.48149,38.34517,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":10,"email":43},"Cristina Alenda González","+34 965913817","alenda.cris@gmail.com",{"facility":45,"status":29,"city":46,"state":10,"zip":10,"country":31,"countryCode":32,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Hopsital Universitari Vall d'Hebron","Barcelona",{"type":34,"coordinates":48},[49,50],2.15899,41.38879,{"lat":50,"lon":49},[53],{"name":54,"role":23,"phone":10,"phoneExt":10,"email":55},"Francisco Ramon Martínez Ricarte","franciscoramon.martinez@vallhebron.cat",{"facility":57,"status":29,"city":58,"state":10,"zip":10,"country":31,"countryCode":32,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Hospital Clínico Universitario Virgen de la Arrixaca","Murcia",{"type":34,"coordinates":60},[61,62],-1.13004,37.98704,{"lat":62,"lon":61},[65],{"name":66,"role":23,"phone":67,"phoneExt":10,"email":68},"Belén Ferri Ñíguez","+34 606884561","belen.ferri@carm.es",{"facility":70,"status":29,"city":71,"state":10,"zip":10,"country":31,"countryCode":32,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hospital Universitario de Canarias","Santa Cruz de Tenerife",{"type":34,"coordinates":73},[74,75],-16.25462,28.46824,{"lat":75,"lon":74},[78],{"name":79,"role":23,"phone":80,"phoneExt":10,"email":81},"Julio Manuel Plata Bello","+34 922678900","jplatbel@ull.edu.es",{"facility":83,"status":29,"city":84,"state":10,"zip":10,"country":31,"countryCode":32,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Hospital Clínic i Universitari de València","Valencia",{"type":34,"coordinates":86},[87,88],-0.37966,39.47391,{"lat":88,"lon":87},[91],{"name":92,"role":23,"phone":93,"phoneExt":10,"email":94},"Vicent Quilis Quesada","+34 963248164","vquilisquesada@gmail.com",{"type":96,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Juan M Garcia-Gomez","Full professor",[100,102,103,105,107],{"name":101,"class":6},"Hospital Clínico Universitario de Valencia",{"name":70,"class":6},{"name":104,"class":6},"Hospital General Universitario de Alicante",{"name":106,"class":6},"Hospital Universitario Virgen de la Arrixaca",{"name":108,"class":6},"Hospital Vall d'Hebron","100601492","feasibility-of-oncohabitats-for-surgical-and-treatment-planning-in-idh-wildtype-glioblastoma-sinue-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":120,"type":121},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.",[125],"Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype",[127,128,129,130,131,132,133,134,135,136,137,138,139],"Glioblastoma","IHD-wildtype","MRI","Biomarkers","Perfussion","Tumor heterogenity","Peritumoral edema","Tumor Infiltration","Machine learning","Medical device validation","Immunosuppression","Overall survival","MGMT status","2025-07-31",{"date":142,"type":143},"2025-08-08","ACTUAL",{"date":145,"type":143},"2024-07-16",{"date":147,"type":121},"2026-09",{"name":97,"class":6},5]