[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610088":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":132,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":23,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":23,"enrollmentInfo":147,"targetDuration":23,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":23,"overallStatus":52,"whyStopped":23,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"177Lu-PSMA-617","EXPERIMENTAL","Patients will begin the first and second cycles of adjuvant Temozolomide (TMZ) the night before the first and second infusions of 177Lu-PSMA-617, respectively. Post-treatment, MRI of the brain will be obtained every 2 months, as per standard of care. A 68Ga-PSMA-PET scan will be performed with the MRI of the brain 1 month after the second cycle of 177Lu-PSMA-617 and again at evidence of disease progression.",[13,14,15,16],"Drug: Temozolomide","Drug: 177Lu-PSMA-617","Diagnostic Test: 68Ga-PSMA-PET scan\u002F MRI","Behavioral: Quality of Life Questionnaires",[18,24,27,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Temozolomide","Patients will begin taking Temozolomide orally on the first 5 days of each 28-day cycle. The first dose will be given the evening before the first infusion of 177Lu-PSMA- 617.",[9],null,{"type":19,"name":9,"description":25,"armGroupLabels":26,"otherNames":23},"This agent will be given for 2-6 total doses, spaced 4 weeks (+\u002F-1 week) apart. This will be administered on the 2nd day of the first two cycles of SOC adjuvant temozolomide.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"DIAGNOSTIC_TEST","68Ga-PSMA-PET scan\u002F MRI","Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"BEHAVIORAL","Quality of Life Questionnaires","baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment",[9],[38],{"name":39,"affiliation":5,"role":40},"Brandon Imber, MD","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":23,"email":45},"CONTACT","631-212-6346","imberb@mskcc.org",{"name":47,"role":43,"phone":48,"phoneExt":23,"email":23},"Thomas Kaley, MD","212-639-5122",[50,66,77,88,100,111,121],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-74.54932,40.70621,{"lat":62,"lon":61},[65],{"name":39,"role":43,"phone":44,"phoneExt":23,"email":23},{"facility":67,"status":52,"city":68,"state":54,"zip":69,"country":56,"countryCode":57,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",{"type":59,"coordinates":71},[72,73],-74.11709,40.39428,{"lat":73,"lon":72},[76],{"name":39,"role":43,"phone":44,"phoneExt":23,"email":23},{"facility":78,"status":52,"city":79,"state":54,"zip":80,"country":56,"countryCode":57,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"type":59,"coordinates":82},[83,84],-74.02292,41.04676,{"lat":84,"lon":83},[87],{"name":39,"role":43,"phone":44,"phoneExt":23,"email":23},{"facility":89,"status":52,"city":90,"state":91,"zip":92,"country":56,"countryCode":57,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":59,"coordinates":94},[95,96],-73.29289,40.84288,{"lat":96,"lon":95},[99],{"name":39,"role":43,"phone":44,"phoneExt":23,"email":23},{"facility":101,"status":52,"city":102,"state":91,"zip":103,"country":56,"countryCode":57,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"type":59,"coordinates":105},[106,107],-73.71263,40.96899,{"lat":107,"lon":106},[110],{"name":39,"role":43,"phone":44,"phoneExt":23,"email":23},{"facility":112,"status":52,"city":91,"state":91,"zip":113,"country":56,"countryCode":57,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":59,"coordinates":115},[116,117],-74.00597,40.71427,{"lat":117,"lon":116},[120],{"name":39,"role":43,"phone":44,"phoneExt":23,"email":23},{"facility":122,"status":52,"city":123,"state":91,"zip":124,"country":56,"countryCode":57,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",{"type":59,"coordinates":126},[127,128],-73.59291,40.70038,{"lat":128,"lon":127},[131],{"name":39,"role":43,"phone":44,"phoneExt":23,"email":23},{"type":133,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[135],{"name":136,"class":137},"Novartis Pharmaceuticals","INDUSTRY","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":148,"type":149},20,"ESTIMATED","INTERVENTIONAL",[152],"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.",[155,156,157,158,159,160],"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","2026-06-02",{"date":163,"type":164},"2026-06-04","ACTUAL",{"date":166,"type":164},"2025-10-27",{"date":168,"type":149},"2027-10",{"name":5,"class":6},7]