GliomaPhase 2NCT06855628
Assessment of Novel Metabolic Imaging Modalities as A Predictor Of Therapeutic EfficacyiIn Glioblastoma (GBM)
A Phase 2 study testing [6,6-²H₂]-Glucose in people with Glioma and GBM, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to evaluate the prognostic capacity of DMI in a trial assessing the efficacy of adding BPM31510, a lipid nano dispersion of CoQ10 to standard treatment of Glioblastoma (GBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- [6,6-²H₂]-Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 13 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any participant that consents to entry into the Phase II BPM31510 parent study (BPM31510IV-11)
- Women of childbearing potential must have a negative pregnancy test
- Ability to understand and the willingness to provide written informed consent.
Who cannot join
- Refuse to have an IV
- Allergy to MRI contrasts
- Diabetic patients who are taking insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment Of A Novel Metabolic Imaging Modalities As A Predictor Of Therapeutic Efficacy In Glioblastoma (GBM)
The goal of this study is to evaluate the prognostic capacity of DMI in a trial assessing the efficacy of adding BPM31510, a lipid nano dispersion of CoQ10 to standard treatment of Glioblastoma (GBM).
- Being tested
- [6,6-²H₂]-Glucose
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[6,6-²H₂]-GlucoseOther
Also called Deuterated Glucose Tracer, Stable Isotope-Labeled Glucose, D-Glucose, [6,6-²H₂]
[6,6-²H₂]-Glucose is a stable isotope-labeled glucose used as a metabolic tracer. It is administered orally to assess glucose metabolism using Deuterium Metabolic Imaging (DMI).
| Study group | Role | What they receive |
|---|---|---|
| Deuterated Glucose + MRI | Experimental | Participants will receive [6,6-²H₂]-glucose orally at a dose of 0.75g per kg of body weight (maximum 60g), dissolved in 200-500mL of water. Approximately 45 minutes after ingestion, participants will undergo an MRI scan consisting of a 30-minute conventional MRI brain study followed by a 1-hour Deuterium Metabolic Imaging (DMI) study. A Gadolinium contrast agent may be administered if more than 4 weeks have passed since the last enhanced MRI scan. Receives: Other: [6,6-²H₂]-Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the start of treatment until disease progression or death from any cause, whichever occurs first
Measured: up to 36 months
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization until death from any cause.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start30 Jan 2025
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lawarence Recht, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855628
- Sponsor's protocol ID
- IRB-77846
- Other IDs
- R01CA277832-02, NCI-2025-01689
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of A Novel Metabolic Imaging Modalities As A Predictor Of Therapeutic Efficacy In Glioblastoma (GBM)
- ClinicalTrials.gov ID
- NCT06855628
- Acronym / sponsor ID
- IRB-77846
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 4 Mar 2025 (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.
The goal of this study is to evaluate the prognostic capacity of DMI in a trial assessing the efficacy of adding BPM31510, a lipid nano dispersion of CoQ10 to standard treatment of Glioblastoma (GBM).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deuterated Glucose + MRI | Experimental | Other: [6,6-²H₂]-GlucoseParticipants will receive [6,6-²H₂]-glucose orally at a dose of 0.75g per kg of body weight (maximum 60g), dissolved in 200-500mL of water. Approximately 45 minutes after ingestion, participants will undergo an MRI scan consisting of a 30-minute conventional MRI brain study followed by a 1-hour Deuterium Metabolic Imaging (DMI) study. A Gadolinium contrast agent may be administered if more than 4 weeks have passed since the last enhanced MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any participant that consents to entry into the Phase II BPM31510 parent study (BPM31510IV-11)
- Women of childbearing potential must have a negative pregnancy test
- Ability to understand and the willingness to provide written informed consent.
Key exclusion criteria (3 listed)
- Refuse to have an IV
- Allergy to MRI contrasts
- Diabetic patients who are taking insulin
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 |
|---|---|---|
| [6,6-²H₂]-GlucoseAlso: Deuterated Glucose Tracer, Stable Isotope-Labeled Glucose, D-Glucose, [6,6-²H₂][6,6-²H₂]-Glucose is a stable isotope-labeled glucose used as a metabolic tracer. It is administered orally to assess glucose metabolism using Deuterium Metabolic Imaging (DMI). | Other | Deuterated Glucose + MRI |
Primary outcome
Progression Free Survival (PFS)
Time frame: up to 36 months
Progression-Free Survival (PFS) is defined as the time from the start of treatment until disease progression or death from any cause, whichever occurs first
Overall Survival (OS)
Time frame: up to 36 months
Overall Survival (OS) is defined as the time from randomization until death from any cause.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
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. This study is not recruiting at the moment.
Lawarence Recht principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [6,6-²H₂]-Glucose in people with Glioma and GBM, run by Stanford University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: up to 36 months). 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 30 Sep 2026.