Assessment of Novel Metabolic Imaging Modalities as A Predictor Of Therapeutic EfficacyiIn Glioblastoma (GBM)

NCT06855628 | Suspended Phase 2

• 2 other identifiers: IRB-77846R01CA277832-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Glioma; GBM

Outcome Measures

Primary Outcomes (2)

• 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

  up to 36 months

• Overall Survival (OS)

  Overall Survival (OS) is defined as the time from randomization until death from any cause.

  up to 36 months

Study Arms (1)

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.

Other: [6,6-²H₂]-Glucose

Interventions

[6,6-²H₂]-Glucose OTHER

\[6,6-²H₂\]-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).

Also known as: Deuterated Glucose Tracer, Stable Isotope-Labeled Glucose, D-Glucose, [6,6-²H₂]

Deuterated Glucose + MRI

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Refuse to have an IV
• Allergy to MRI contrasts
• Diabetic patients who are taking insulin

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Glucose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Lawarence Recht

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (1)