GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma

NCT07852975 | Not Yet Recruiting DMC

• 2 other identifiers: J2672IRB00564365
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Glioma (Glioblastoma Multiforme)

Keywords

Recurrent Glioma prior to required surgery

Outcome Measures

Primary Outcomes (2)

• 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).

• 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

Secondary Outcomes (4)

• Proportion of patients achieving beta-hydroxybuterate (Analysis of metabolic marker BHB)

  Day 7 of diet intervention.

• Change in beta-hydroxybuterate (BHB) on Magnetic Resonance Imaging and Spectroscopy (MRS) with intervention

  Pre-treatment and Day 7

• Detection of Acetone (mL)

  Pre-treatment and Day 7

• Time spent in ketosis

  Days 1, 3, and 7

Study Arms (2)

Ketone supplement

EXPERIMENTAL

Patients will self-administer a ketone supplement 80 mg for 7 days leading up to the surgery

Dietary Supplement: Arm 1 will use Ketone supplement 80 gm daily

Ketone diet

EXPERIMENTAL

Patients will follow a 2.5:1 - 3:1 ketogenic diet (KD) daily for 7 days leading up to the clinically indicated surgery.

Other: Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery.

Interventions

Arm 1 will use Ketone supplement 80 gm daily DIETARY_SUPPLEMENT

Arm 1 will use Ketone supplement 80 gm daily

Ketone supplement

Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery. OTHER

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.

Ketone diet

Eligibility Criteria

• Age: 18 Years - 111 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologic diagnosis of a glioma that has received prior irradiation and is presumed recurrent.
• Clinical indication for open biopsy or surgical resection.
• On MRI, a 2x2x2 cm enhancement absent of bleed, calcification, or other features that can obscure MRS signal.
• Karnofsky performance status ≥ 70.
• Age \> 18 years.
• Willing to submit archival tumor sample if available.
• Patients must have the following organ and marrow function:
• Absolute neutrophil count \>1,000/mcL
• Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) OR total bilirubin \>1.5 × ULN with direct bilirubin \< 1.5 × ULN;
• AST (SGOT) and ALT (SGPT) \< 2.5 x institutional ULN
• PT or PTT \< 1.5 x institutional ULN
• Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 calculated by the CKD-EPI equation
• Patients must be maintained on a stable or decreasing dose of systemic corticosteroid regimen of dexamethasone \< 4mg (no increase for 5 days) prior to start of study intervention (Day 1). Topical and inhaled steroid treatment is allowed.
• Patient must be able to provide written informed consent.
• Female participants of childbearing potential must have a negative serum pregnancy test prior to study start.

You may not qualify if:

• 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.
• Active uncontrolled infection.
• BMI \< 20.0.
• Active bowel obstruction, ileus, or active or remote pancreatitis, known gastroparesis/delayed gastric emptying.
• Known history of clinically significant heart failure (NYHA \>2), recent myocardial infarction, or symptomatic atrial fibrillation.
• 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)
• Conditions that may increase the risk of study intervention or significantly reduce compliance (i.e. cognitive impairment, frank dementia, etc.).
• Other concurrent experimental therapies.
• Food restrictions that would limit study diet adherence.
• Contraindication to receiving an MRI (cardiac pacemaker, insulin pumps, non-MRI-compatible stents/clips/plates/rods, non-removable glucose monitor, other non-removable ferromagnetic objects in the body, etc.).

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: collaborator
• Kenetik: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Oncology- Broadway

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Karisa C Schreck, MD, PhD.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karisa C Schreck, MD, PhD.

CONTACT

410-995-8837; ksolt1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2029
• Study Completion (Estimated): October 15, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

US (1)