[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gliomas-harboring-idh1-andor-idh2-mutations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gliomas-harboring-idh1-andor-idh2-mutations":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100637209","multicenter-prospective-study-on-mri-ai-model-for-midline-glioma-subtyping-and-prognosis-100637209",false,"NCT07608003","Multicenter Prospective Study on MRI AI Model for Midline Glioma Subtyping and Prognosis:","Application of MRI-Based Artificial Intelligence Models for Preoperative Molecular Subtyping and Prognostic Assessment of Midline Gliomas: A Multicenter Prospective Clinical Study","Inclusion Criteria:\n\n* Patients with diffuse gliomas were pathologically and molecularly diagnosed.\n* The clinical case data of all patients were complete.\n* Patients underwent preoperative MRI examination.\n\nExclusion Criteria:\n\n* The tumor is not located in the intracranial midline.\n* Cases in which MRI were incomplete or with significant noise and artifacts.","ALL",{"count":18,"type":19},500,"ESTIMATED","3 Years","OBSERVATIONAL","A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p\u002F19q. This prospective multicenter study will validate the model's accuracy in preoperative molecular subtyping and its value in prognostic assessment and clinical decision-making across multiple neurosurgical centers.",[24,25,26,27,28,29],"Gliomas Harboring IDH1 and\u002For IDH2 Mutations","Glioma Glioblastoma Multiforme","Glioma of Brainstem","Glioma, Diffuse Midline, H3K27M-mutant","Glioma : Oligodendroglioma or Astrocytoma","Gliomas",[31,32,33,34],"Midline gliomas","Molecular diagnosis","Foundation model","Prognosis prediction","RECRUITING","2026-05-25",{"date":38,"type":39},"2026-05-27","ACTUAL",{"date":41,"type":19},"2026-05-10",{"date":43,"type":19},"2030-12-31",{"name":45,"class":46},"Xiangya Hospital of Central South University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":47},"100594866","phase-1-phase-i-study-of-hmpl-306-for-the-treatment-of-gliomas-with-idh1-andor-idh2-mutations-100594866","NCT07025018","Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and\u002For IDH2 Mutations","A Multicenter, Randomized Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of HMPL-306 in Patients With Gliomas Harboring IDH1 and\u002For IDH2 Mutations","Inclusion Criteria:\n\n1. Fully informed about the study and voluntarily sign the informed consent form (ICF).\n2. Age ≥ 18 years.\n3. Safety Lead-In Phase: Patients with gliomas of a documented IDH1 and\u002For IDH2 mutation. Perioperative Study Phase: Patients with gliomas of definitive or suspected IDH1 and\u002For IDH2 mutations scheduled for surgery.\n4. All patients must have at least one measurable lesion.\n5. Karnofsky Performance Status (KPS) score ≥ 80% .\n6. In the investigator's judgment, a life expectancy of ≥ 12 weeks.\n7. Sufficient bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Previous treatment with IDH inhibitors.\n2. Unresolved toxicity from previous antitumor treatments not reverted to ≤ Grade 1 (except for alopecia, skin pigmentation changes, and ≤ Grade 2 peripheral neuropathy).\n3. Patients assessed by researchers to have high-risk or unstable conditions.\n4. Having other malignancies or a history of other malignancies within 5 years prior to screening.\n5. History of clinically significant liver disease, including active infection with viral hepatitis, or other active hepatitis, alcoholic liver disease, cirrhosis, etc.\n6. Patients with HIV infection.\n7. Pregnancy (positive pregnancy test before dosing) or currently breastfeeding women.\n8. Presence of diseases or conditions affecting drug absorption.\n9. Any other conditions, in the investigator's judgment, unsuitable for the study drug, will result in exclusion.","18 Years",{"count":57,"type":19},52,"INTERVENTIONAL",[60],"PHASE1","This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1 and\u002For IDH2 mutations",[24],[64,65,66,67,68,69,70,71,72,73,74,75,76,77],"gliomas","randomized controlled","Multicenter","IDH1 mutations","IDH2 mutations","safety run-in","MRI\u002FMRS examination","Phase I","clinical study","pharmacokinetics (PK)","pharmacodynamics (PD)","efficacy","HMPL-306","perioperative study","2025-07-31",{"date":80,"type":39},"2025-08-01",{"date":82,"type":39},"2025-07-15",{"date":84,"type":19},"2027-12",{"name":86,"class":87},"Hutchmed","INDUSTRY"]