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

Stanford University

Status and phase: Suspended; Phase 2

Conditions: Glioma; GBM

Treatments: Other: [6,6-²H₂]-Glucose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06855628

R01CA277832-02 (U.S. NIH Grant/Contract)

IRB-77846

Details and patient eligibility

About

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Deuterated Glucose + MRI

Experimental group

Description:

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.

Treatment:

Other: [6,6-²H₂]-Glucose