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

Phase 2

Recruiting

• Conditions: Glioma; GBM

• Registration Number: NCT06855628
• Lead Sponsor: Stanford University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-30
• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Primary Completion: 2028-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States