[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658562":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":56,"overallOfficials":65,"centralContacts":70,"locations":75,"responsibleParty":89,"collaborators":91,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":36,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":118,"whyStopped":36,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"Feasibility as assessed by Proportion of patients who complete 80% or more of the study intervention","Proportion of patients who complete 80% or more of the study intervention","Enrollment, day 7 of diet intervention, immediately after surgery, and follow-up up to 30 days post intervention).",{"measure":14,"description":15,"timeFrame":16},"Safety as assessed by incidence and severity of treatment-associated adverse events","Safety as measured by incidence and severity of treatment-associated adverse events attributed to study intervention as graded by the CTCAE v6.0","Enrollment, day 7 of diet intervention, immediately after surgery, follow-up up to 30 days post intervention",[18,22,26,29,32],{"measure":19,"description":20,"timeFrame":21},"Proportion of patients achieving beta-hydroxybuterate (Analysis of metabolic marker BHB)","Proportion of patients achieving beta-hydroxybuterate (BHB) on MRS (BHB\u002FtCr ratio) greater than 1.0 at Day 7 of intervention.","Day 7 of diet intervention.",{"measure":23,"description":24,"timeFrame":25},"Change in beta-hydroxybuterate (BHB) on Magnetic Resonance Imaging with intervention","Change in beta-hydroxybuterate (BHB) on Magnetic Resonance Imaging (MRI)","Pre-treatment and Day 7",{"measure":27,"description":28,"timeFrame":25},"Change in beta-hydroxybuterate (BHB) on Spectroscopy (MRS)","Change in beta-hydroxybuterate (BHB) on Spectroscopy (MRS) with intervention (BHB\u002FtCr ratio D7 vs pre-treatment)",{"measure":30,"description":31,"timeFrame":25},"Detection of Acetone (mL)","Detection of Acetone on MRS with intervention",{"measure":33,"description":34,"timeFrame":35},"Time spent in ketosis","Time spent in ketosis (hours per 24 where blood BHB \\> 0.9 mM)","Days 1, 3, and 7",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":6,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","SINGLE_GROUP","Subjects are randomized in 1:1 ratio to self-administer a ketone supplement (KS) or follow a 2.5:1 - 3:1 ketogenic diet (KD) daily for 7 days leading up to the surgery, at which time some tumor tissue will be contributed for the research protocol. Blood and in vivo brain MR spectroscopy (MRS) will be evaluated before and after treatment.",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE","The primary objective of the study is to determine the feasibility and safety of short-term ketone supplementation or a ketogenic diet in patients with recurrent glioma for seven days prior to surgery.\n\nThe secondary objective of the study is to assess the physiologic effects of a 7-day ketone supplementation or ketogenic diet on tumor and systemic metabolism as measured by ketones (BHB and ACE) on MR spectroscopy (MRS) and blood ketone levels (hours per 24 where BHB \\> 0.9 mM).",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Ketone supplement","EXPERIMENTAL","Patients will self-administer a ketone supplement 80 mg for 7 days leading up to the surgery",[50],"Dietary Supplement: Arm 1 will use Ketone supplement 80 gm daily",{"label":52,"type":47,"description":53,"interventionNames":54},"Ketone diet","Patients will follow a 2.5:1 - 3:1 ketogenic diet (KD) daily for 7 days leading up to the clinically indicated surgery.",[55],"Other: Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery.",[57,61],{"type":58,"name":59,"description":59,"armGroupLabels":60,"otherNames":36},"DIETARY_SUPPLEMENT","Arm 1 will use Ketone supplement 80 gm daily",[46],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":36},"Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery.","Arm 2 participants will follow a 2.5:1 - 3:1 ketogenic diet (KD) daily for 7 days leading up to the clinically indicated surgery.",[52],[66],{"name":67,"affiliation":68,"role":69},"Karisa C Schreck, MD, PhD.","Johns Hopkins University","PRINCIPAL_INVESTIGATOR",[71],{"name":67,"role":72,"phone":73,"phoneExt":36,"email":74},"CONTACT","410-995-8837","ksolt1@jhmi.edu",[76],{"facility":77,"status":36,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":36},"Oncology- Broadway","Baltimore","Maryland","21287","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-76.61219,39.29038,{"lat":87,"lon":86},{"type":90,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[92,94],{"name":93,"class":6},"Ludwig Institute for Cancer Research",{"name":95,"class":96},"Kenetik","UNKNOWN","100658562","glad-ke-glioma-biomarker-and-safety-assessment-during-dietary-ketone-elevation-subtitle-a-surgical-biomarker-discovery-study-of-ketogenic-therapy-in-recurrent-glioma-100658562",false,"NCT07852975","GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma","GLAD-KE","Inclusion Criteria:\n\n* Histopathologic diagnosis of a glioma that has received prior irradiation and is presumed recurrent.\n* Clinical indication for open biopsy or surgical resection.\n* On MRI, a 2x2x2 cm enhancement absent of bleed, calcification, or other features that can obscure MRS signal.\n* Karnofsky performance status ≥ 70.\n* Age \\> 18 years.\n* Willing to submit archival tumor sample if available.\n* Patients must have the following organ and marrow function:\n* Absolute neutrophil count \\>1,000\u002FmcL\n* Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) OR total bilirubin \\>1.5 × ULN with direct bilirubin \\\u003C 1.5 × ULN;\n* AST (SGOT) and ALT (SGPT) \\\u003C 2.5 x institutional ULN\n* PT or PTT \\\u003C 1.5 x institutional ULN\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m2 calculated by the CKD-EPI equation\n* Patients must be maintained on a stable or decreasing dose of systemic corticosteroid regimen of dexamethasone \\\u003C 4mg (no increase for 5 days) prior to start of study intervention (Day 1). Topical and inhaled steroid treatment is allowed.\n* Patient must be able to provide written informed consent.\n* Female participants of childbearing potential must have a negative serum pregnancy test prior to study start.\n* Patients who have received prior ketogenic therapy (including supplements and diet) may enroll, but must have stopped prior therapy ≥ 7 days prior to day 1.\n* Patient willing to minimize carbohydrate-containing medications.\n\nExclusion Criteria:\n\n* Patients with a history of a metabolic disorder including documented defect in urea metabolism (including documented history of gout), carnitine deficiency (primary carnitine deficiency, carnitine palmitoyl transferase I or II deficiency, carnitine translocase deficiency), fatty acid metabolism, beta-oxidation defects, pyruvate carboxylase deficiency, mitochondrial function, porphyria, or treatment refractory nephrolithiasis.\n* Active uncontrolled infection.\n* BMI \\\u003C 20.0.\n* Active bowel obstruction, ileus, or active or remote pancreatitis, known gastroparesis\u002Fdelayed gastric emptying.\n* Known history of clinically significant heart failure (NYHA \\>2), recent myocardial infarction, or symptomatic atrial fibrillation.\n* Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications to treat diabetes (note, use of medications for weight loss that have been FDA approved for diabetes is acceptable)\n* Conditions that may increase the risk of study intervention or significantly reduce compliance (i.e. cognitive impairment, frank dementia, etc.).\n* Other concurrent experimental therapies.\n* Food restrictions that would limit study diet adherence.\n* Contraindication to receiving an MRI (cardiac pacemaker, insulin pumps, non-MRI-compatible stents\u002Fclips\u002Fplates\u002Frods, non-removable glucose monitor, other non-removable ferromagnetic objects in the body, etc.).","ALL","18 Years","111 Years",{"count":108,"type":109},20,"ESTIMATED","INTERVENTIONAL",[112],"NA","This study is being done to see if a Ketogenic Diet (KD) or short-term Ketone supplement (KS) is feasible and safe for patients with recurrent Glioma who are undergoing a clinically indicated surgery.",[115],"Recurrent Glioma (Glioblastoma Multiforme)",[117],"Recurrent Glioma prior to required surgery","NOT_YET_RECRUITING","2026-10-01",{"date":121,"type":122},"2026-10-06","ACTUAL",{"date":124,"type":109},"2026-10-15",{"date":126,"type":109},"2030-10-15",{"name":5,"class":6},1]