GBM, Glioma
Conditions
Brief 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).
Interventions
OTHER[6,6-²H₂]-Glucose
\[6,6-²H₂\]-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).
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Refuse to have an IV * Allergy to MRI contrasts * Diabetic patients who are taking insulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 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) | up to 36 months | Overall Survival (OS) is defined as the time from randomization until death from any cause. |
Countries
United States
Outcome results
None listed