[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-astrocytoma-idh-wildtype-grade-2-4\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-astrocytoma-idh-wildtype-grade-2-4":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100610088","phase-1-a-study-of-177lu-psma-617-in-people-with-gliomas-100610088",false,"NCT07223034","A Study of 177Lu-PSMA-617 in People With Gliomas","LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment","Inclusion Criteria:\n\n* Confirmed histologic diagnosis of a WHO grade 2-4 glioma that is IDH1 R132H-wildtype, including the following:\n\n  * Diffuse astrocytoma, IDH-wildtype (grade 2-4)\n  * Glioblastoma, IDH-wildtype\n  * Diffuse midline glioma, H3 K27-altered\n  * Diffuse hemispheric glioma, H3 G34-mutant\n  * Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype PSMA positive pathological stain (by immunohistochemistry) of baseline (pre-radiotherapy) resection or biopsy sample\n* Completion of standard of care therapy including surgery (for resectable tumors) and adjuvant EBRT for glioma\n* Patients must be on a dose of 4 mg or less of dexamethasone (or dexamethasone equivalent steroid) for 5 days prior to first planned dose of radiopharmaceutical\n* Age ≥ 18\n* ECOG ≤ 2\n* Serum creatinine level \\\u003C 1.5 x ULN or EGFR \\> 60 mL\u002Fmin\n* Liver laboratory values: ALT and AST ≤ 2.5 x ULN; Albumin \\> 2 g\u002F dL; Bilirubin \\\u003C 3 X ULN\n* Normal organ and marrow function as defined as the following\n\n  * Total white blood count \\> 3.0 K\u002FmcL\n  * ANC ≥ 1.5 K\u002FmcL\n  * Platelets ≥ 100 K\u002FmcL\n  * Hemoglobin ≥ 9 g\u002FdL\n* Adequate contraception prior to registration (see section 9.0)\n* Ability to understand, and willingness to sign the informed consent.\n\nExclusion Criteria:\n\n* Patient known to harbor any other non-canonical IDH mutations (i.e., non-R132H)\n* Target lesion within 5 mm of either the brainstem, optic chiasm or optic nerves Receipt of bevacizumab as part of the initial treatment for glioma\n* Life expectancy less than 12 weeks\n* Nonhealing wound, ulcer or bone fracture\n* History of severe brain injury\n* Patient not eligible for sequential MRI evaluations\n* Patients with prior RT to \\> 25% of the skeleton or prior exposure to prior Radium223, Strontium89 or Samarium153 containing compounds\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Unable to tolerate the PSMA PET\u002FMR or PSMA PET\u002FCT\n* History of viral hepatitis or chronic liver disease with active symptoms\n* History of pituitary or adrenal dysfunction\n* Previously diagnosed active infection (e.g., human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n* Any condition that in the opinion of the investigator, would preclude participation in this study\n* Receipt of any other investigational agents or participation in a concurrent treatment protocol\n* Known allergies, hypersensitivities, or intolerance to 68Ga-PSMA-11\u002F177Lu-PSMA-617 or its inactive compounding components\n* Current or planned pregnancy\n* Refusal to comply with detailed contraception requirements","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The researchers are doing this study to find out whether the radiopharmaceutical therapy (RPT) 177Lu-PSMA-617 is a safe treatment for people with IDH wild type glioma.",[26,27,28,29,30,31],"Glioma","Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4)","Glioblastoma, IDH-wildtype","Diffuse Midline Glioma, H3 K27-Altered","Diffuse Hemispheric Glioma, H3 G34-mutant","Diffuse Pediatric-type High-grade Glioma, H3-wildtype and IDH-wildtype","RECRUITING","2026-06-02",{"date":35,"type":36},"2026-06-04","ACTUAL",{"date":38,"type":36},"2025-10-27",{"date":40,"type":20},"2027-10",{"name":42,"class":43},"Memorial Sloan Kettering Cancer Center","OTHER",7]