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

NCT ID: NCT06855628

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2028-02-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Deuterated Glucose + MRI

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.

Group Type: EXPERIMENTAL

[6,6-²H₂]-Glucose

Intervention Type: 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).

Interventions

[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).

Intervention Type: OTHER

Other Intervention Names

Deuterated Glucose Tracer; Stable Isotope-Labeled Glucose; D-Glucose, [6,6-²H₂]

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawarence Recht

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

R01CA277832-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-77846

Identifier Type: -

Identifier Source: org_study_id