[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441586":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":120,"centralContacts":124,"locations":130,"responsibleParty":162,"collaborators":52,"id":164,"slug":165,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":52,"eligibilityCriteria":170,"healthyVolunteers":166,"sex":171,"minAge":172,"maxAge":52,"enrollmentInfo":173,"targetDuration":52,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":52,"overallStatus":133,"whyStopped":52,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (stereotactic biopsy, radiosurgery, surgery)","EXPERIMENTAL","Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.",[13,14,15,16,17,18,19,20,21],"Radiation: Radiation Therapy","Radiation: Radiosurgery","Procedure: Stereotactic Biopsy","Drug: Temozolomide","Procedure: Tumor Treating Fields Therapy","Procedure: Magnetic Resonance Imaging","Procedure: Biospecimen Collection","Procedure: Biopsy","Procedure: Therapeutic Conventional Surgery",[23,40,47,53,73,81,101,109,116],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Radiation Therapy","Undergo radiation therapy",[9],[29,30,31,32,33,34,35,36,37,38,39],"Cancer Radiotherapy","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",{"type":24,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Radiosurgery","Undergo radiosurgery",[9],[45,46],"Ablation, Radiosurgical","Radiation Surgery",{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"PROCEDURE","Stereotactic Biopsy","Undergo MRI-guided stereotactic biopsy",[9],null,{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","Temozolomide","Drug",[9],[59,60,61,62,63,64,65,66,67,68,69,70,71,72],"CCRG-81045","Gliotem","Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-","M & B 39831","M and B 39831","Methazolastone","RP-46161","SCH 52365","Temcad","Temizole","Temodal","Temodar","Temomedac","TMZ",{"type":48,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Tumor Treating Fields Therapy","Undergo TTF",[9],[78,79,80],"Alternating Electric Field Therapy","TTF","TTFields",{"type":48,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"Magnetic Resonance Imaging","Undergo MRI",[9],[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","nuclear magnetic resonance imaging","sMRI","Structural MRI",{"type":48,"name":102,"description":103,"armGroupLabels":104,"otherNames":105},"Biospecimen Collection","Undergo blood sample collection",[9],[106,107,108],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":48,"name":110,"description":111,"armGroupLabels":112,"otherNames":113},"Biopsy","Undergo biopsy",[9],[114,115],"BIOPSY_TYPE","Bx",{"type":48,"name":117,"description":118,"armGroupLabels":119,"otherNames":52},"Therapeutic Conventional Surgery","Undergo surgery",[9],[121],{"name":122,"affiliation":5,"role":123},"Daniel M. Trifiletti, MD","PRINCIPAL_INVESTIGATOR",[125],{"name":126,"role":127,"phone":128,"phoneExt":52,"email":129},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[131,149],{"facility":132,"status":133,"city":134,"state":135,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":144,"contacts":145},"Mayo Clinic in Arizona","RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":140,"coordinates":141},"Point",[142,143],-112.07404,33.44838,{"lat":143,"lon":142},[146,147],{"name":126,"role":127,"phone":128,"phoneExt":52,"email":129},{"name":148,"role":123,"phone":52,"phoneExt":52,"email":52},"Sujay Vora, MD",{"facility":150,"status":133,"city":151,"state":152,"zip":153,"country":137,"countryCode":138,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Mayo Clinic in Florida","Jacksonville","Florida","32224-9980",{"type":140,"coordinates":155},[156,157],-81.65565,30.33218,{"lat":157,"lon":156},[160,161],{"name":126,"role":127,"phone":128,"phoneExt":52,"email":129},{"name":122,"role":123,"phone":52,"phoneExt":52,"email":52},{"type":163,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100441586","phase-1-preoperative-radiosurgery-for-the-treatment-of-high-grade-glioma-neoglioma-trial-100441586",false,"NCT05030298","Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial","Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization \\[WHO\\] grade III-IV, including glioblastoma) regardless of IDH and MGMT status\n* Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment\n* Planned neurosurgical resection of tumor\n* Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Negative pregnancy test done =\\\u003C 14 days prior to registration, for women of childbearing potential only. Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test.\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide written informed consent\n* Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration\n* Willing to provide tissue and\u002For blood samples for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women who are unwilling to cease during therapy\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Prior history of cranial radiotherapy\n* Unwillingness to participate in study\n* Investigator discretion that enrollment on the study would pose undo harm or risk to the patient\n* Non-MRI compatible implanted medical device\n* Use of systemic anti-cancer therapy within the previous 3 months\n* Medical contraindication to craniotomy and tumor resection\n* Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor\n\n  * Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor\n* Primary spinal cord glioma or primary brainstem glioma\n* Residual tumor of excessive volume or eloquent location per investigator discretion\n* Patients who are unwilling or unable to comply with study procedures","ALL","18 Years",{"count":174,"type":175},28,"ESTIMATED","INTERVENTIONAL",[178],"PHASE1","This phase I trial finds out the possible benefits and\u002For side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.",[181],"Malignant Glioma","2026-04-20",{"date":184,"type":185},"2026-04-22","ACTUAL",{"date":187,"type":185},"2023-05-23",{"date":189,"type":175},"2027-09-15",{"name":5,"class":6},2]