Recurrent Glioma (Glioblastoma Multiforme)GLAD-KENCT07852975
GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma
A study testing Arm 1 will use Ketone supplement 80 gm daily and Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery. in people with Recurrent Glioma (Glioblastoma Multiforme), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 111 years
- Conditions the study is for
- Recurrent Glioma (Glioblastoma Multiforme)
- What is being tested?
- Arm 1 will use Ketone supplement 80 gm daily and Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2026to 15 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 111 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
- Patient willing to minimize carbohydrate-containing medications.
Who cannot join
- 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)
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- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
The 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).
- Being tested
- Arm 1 will use Ketone supplement 80 gm daily, Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery.
- Keywords
- Recurrent Glioma prior to required surgery
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 will use Ketone supplement 80 gm dailyDietary supplement
Arm 1 will use Ketone supplement 80 gm daily
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketone supplement | Experimental | Patients will self-administer a ketone supplement 80 mg for 7 days leading up to the surgery Receives: 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. Receives: Other: Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Enrollment, day 7 of diet intervention, immediately after surgery, follow-up up to 30 days post intervention
Secondary outcomes (5)
Proportion of patients achieving beta-hydroxybuterate (Analysis of metabolic marker BHB)
Proportion of patients achieving beta-hydroxybuterate (BHB) on MRS (BHB/tCr ratio) greater than 1.0 at Day 7 of intervention.
Measured: Day 7 of diet intervention.
Change in beta-hydroxybuterate (BHB) on Magnetic Resonance Imaging with intervention
Change in beta-hydroxybuterate (BHB) on Magnetic Resonance Imaging (MRI)
Measured: Pre-treatment and Day 7
Change in beta-hydroxybuterate (BHB) on Spectroscopy (MRS)
Change in beta-hydroxybuterate (BHB) on Spectroscopy (MRS) with intervention (BHB/tCr ratio D7 vs pre-treatment)
Measured: Pre-treatment and Day 7
Detection of Acetone (mL)
Detection of Acetone on MRS with intervention
Measured: Pre-treatment and Day 7
Time spent in ketosis
Time spent in ketosis (hours per 24 where blood BHB > 0.9 mM)
Measured: Days 1, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start5 Nov 2026 (estimated)
- Primary completion15 Nov 2029 (estimated)
- Study completion15 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioma (Glioblastoma Multiforme)Studies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Institute for Cancer Research, Kenetik
- Responsible party
- Sponsor
- Investigators
- Karisa C Schreck, MD, PhD., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852975
- Sponsor's protocol ID
- J2672
- Other IDs
- IRB00564365
- Acronym
- GLAD-KE
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma
- ClinicalTrials.gov ID
- NCT07852975
- Acronym / sponsor ID
- GLAD-KE / J2672
- Keywords
- Recurrent Glioma prior to required surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Ludwig Institute for Cancer Research, Kenetik
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2029 (estimated)
- Study completion
- 15 Oct 2030 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketone supplement | Experimental | Dietary Supplement: Arm 1 will use Ketone supplement 80 gm dailyPatients will self-administer a ketone supplement 80 mg for 7 days leading up to the surgery |
| Ketone diet | Experimental | Other: Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery.Patients will follow a 2.5:1 - 3:1 ketogenic diet (KD) daily for 7 days leading up to the clinically indicated surgery. |
Who may qualify
- Ages
- 18 to 111 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 will use Ketone supplement 80 gm dailyArm 1 will use Ketone supplement 80 gm daily | Dietary supplement | Ketone supplement |
| 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. | Other | Ketone diet |
Primary outcome
Feasibility as assessed by Proportion of patients who complete 80% or more of the study intervention
Time frame: Enrollment, day 7 of diet intervention, immediately after surgery, and follow-up up to 30 days post intervention).
Proportion of patients who complete 80% or more of the study intervention
Safety as assessed by incidence and severity of treatment-associated adverse events
Time frame: Enrollment, day 7 of diet intervention, immediately after surgery, follow-up up to 30 days post intervention
Safety as measured by incidence and severity of treatment-associated adverse events attributed to study intervention as graded by the CTCAE v6.0
5 secondary outcomes
Proportion of patients achieving beta-hydroxybuterate (Analysis of metabolic marker BHB)
Time frame: Day 7 of diet intervention.
Change in beta-hydroxybuterate (BHB) on Magnetic Resonance Imaging with intervention
Time frame: Pre-treatment and Day 7
Change in beta-hydroxybuterate (BHB) on Spectroscopy (MRS)
Time frame: Pre-treatment and Day 7
Detection of Acetone (mL)
Time frame: Pre-treatment and Day 7
Time spent in ketosis
Time frame: Days 1, 3, and 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karisa C Schreck, MD, PhD. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 will use Ketone supplement 80 gm daily and Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery. in people with Recurrent Glioma (Glioblastoma Multiforme), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karisa C Schreck, MD, PhD. (410-995-8837, ksolt1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by Proportion of patients who complete 80% or more of the study intervention (time frame: Enrollment, day 7 of diet intervention, immediately after surgery, and follow-up up to 30 days post intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.