[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633849":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":30,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":10,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":52,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":10},{"fullName":5,"class":6},"IRCCS Ospedale San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with radiologically suspected, treatment-naïve high-grade gliomas",null,"Adult patients with suspected high-grade glioma undergoing standard-of-care MRI evaluation and neurosurgical procedures (stereotactic biopsy or surgical resection). Imaging data and tissue samples will be collected and analyzed to investigate imaging biomarkers of tumor infiltration.",[13],"Diagnostic Test: Standard-of-care MRI data, including APT and diffusion imaging, will be analyzed to generate quantitative maps of tumor infiltration within the peri-tumoral region.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Standard-of-care MRI data, including APT and diffusion imaging, will be analyzed to generate quantitative maps of tumor infiltration within the peri-tumoral region.","Advanced MRI data acquired as part of standard-of-care imaging, including amide proton transfer (APT) and diffusion tensor imaging (DTI), will be processed using dedicated post-hoc image analysis pipelines. A habitat-based clustering approach combining APT-derived MTRasym and DTI-derived mean diffusivity maps will be applied to generate a quantitative Tumor Infiltration Probability Map (TIPM). This imaging biomarker will be used to characterize peri-tumoral tissue heterogeneity and investigate tumor infiltration patterns for research purposes only.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Gianluca Nocera, MD, PhD","CONTACT","0039 0226433007","nocera.gianluca@hsr.it",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Nocera Gianluca","MD, PhD",[31],{"name":32,"class":6},"Fondazione Umberto Veronesi","100633849","apt-weighted-and-diffusion-mri-for-characterizing-tumor-infiltration-in-high-grade-gliomas-100633849",false,"NCT07532031","APT-weighted and Diffusion MRI for Characterizing Tumor Infiltration in High-Grade Gliomas","Characterization of Peri-tumoral Microenvironment in High-grade Gliomas Through the Combined Use of APT-weighted Imaging and Diffusion MRI","APT-HGG","Inclusion Criteria:\n\n1. Adult patients (both male and female, \\>= 18 years old)\n2. Previously acquired MRI suggestive for the presence of high-grade glioma\n3. Treatment-naïve status, defined as no prior surgical, radiotherapeutic, or systemic oncological treatment for the index brain lesion.\n4. Indication for biopsy or tumor resection\n5. Willingness to participate to the study and ability to sign informed consent\n\nExclusion Criteria:\n\n1. Pregnancy (to be excluded through a human chorionic gonadotropin pregnancy test performed on urine or serum when childbearing potential) and \u002F or lactation.\n2. Contraindications to MRI because of:\n\n   I. Claustrophobia II. Presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) III. Sickle cell disease IV. Renal failure or reduced renal function, as determined by Glomerular Filtration Rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2 based on a serum creatinine level obtained within 40 days prior to registration\n3. Presence of any other co-existing condition (such as serious systemic illness, including uncontrolled intercurrent infection, uncontrolled malignancy, significant renal or hepatic disease, or psychiatric\u002Fsocial situations) which might, in the judgment of the investigator, increase the risks to the subject or limit compliance with study requirements\n4. Inability to undergo surgical procedures\n5. Severe hepatic impairment, defined as the presence of two or more of the following parameters (assessed within 40 days): bilirubin ≥3 mg\u002FdL, albumin \\\u003C2.8 g\u002FdL, International normalized ratio \\>2.3 with no history of anticoagulant therapy, platelet count \\\u003C 100 109\u002FL, AST ≥ 400 U\u002FL, ALT ≥400 U\u002FL, presence of ascites.","ALL","18 Years",{"count":44,"type":45},20,"ESTIMATED","OBSERVATIONAL","High-grade gliomas are the most common primary malignant brain tumors and are characterized by infiltration of the surrounding brain tissue beyond the visible tumor margins. This infiltrative growth represents a major challenge for treatment planning and contributes to tumor recurrence. Conventional magnetic resonance imaging (MRI) is limited in its ability to distinguish tumor infiltration from non-tumoral changes such as vasogenic edema in the peri-tumoral region.\n\nThis prospective single-center observational study aims to improve the characterization of the peri-tumoral microenvironment in patients with suspected high-grade gliomas using advanced MRI techniques, including amide proton transfer-weighted (APTw) imaging and diffusion tensor imaging (DTI). These techniques provide complementary information about tissue composition and microstructure and may help identify areas of tumor infiltration that are not visible on conventional imaging.\n\nAPTw- and DTI-derived maps will be combined to generate imaging-derived maps describing the likelihood of tumor infiltration within the peri-tumoral region. These maps will be compared with histopathological findings obtained from tissue samples collected during biopsy or tumor resection performed as part of standard clinical care. Histological analyses will include assessment of tumor cellularity using hematoxylin and eosin staining and additional immunohistochemical markers routinely used in neuropathological evaluation. Patients will undergo routine clinical follow-up and the prognostic significance of the imaging-derived map will be assessed.\n\nThe overall goal of the study is to develop and validate imaging-based biomarkers capable of identifying infiltrated tissue within the peri-tumoral region. These findings may contribute to improved diagnostic accuracy and support future treatment planning strategies in patients with high-grade gliomas.",[49,50,51],"High-Grade Glioma","Glioblastoma","Brain Tumor Adult",[53,54,55,56,50],"Amide Proton Transfer Imaging","Diffusion Tensor Imaging","Imaging Biomarkers","High-grade glioma","NOT_YET_RECRUITING","2026-04-08",{"date":60,"type":61},"2026-04-15","ACTUAL",{"date":63,"type":45},"2026-04-01",{"date":65,"type":45},"2029-04",{"name":5,"class":6}]