Skip to content

Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06054529
Acronym
GBM-FLUX2
Enrollment
2
Registered
2023-09-26
Start date
2023-09-11
Completion date
2025-12-31
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Brief summary

To learn how altered metabolism in GBM causes tumor growth and resistance to drug therapy. In this pilot research study, we will dose GBM patients with a form of nicotinamide (a natural vitamin) that we can track. The nicotinamide will be converted to methyl nicotinamide (MeNAM) in the tumor. We will measure how fast the nicotinamide is converted to methyl nicotinamide. We believe that the speed of this chemical reaction in the tumor (fast versus slow) may be correlated with GBM aggressiveness

Interventions

PROCEDURESurgical removal of the GBM tumor

Surgical removal of the GBM tumor

OTHERd4-NAM infusion

Following the surgical removal of the GBM tumor, GBM patients will be dosed with a form of nicotinamide (a natural vitamin) that we can track. The nicotinamide will be converted to methyl nicotinamide (MeNAM) in the tumor. We will measure how fast the nicotinamide is converted to methyl nicotinamide. We believe that the speed of this chemical reaction in the tumor (fast versus slow) may be correlated with GBM aggressiveness.

Sponsors

AdventHealth Translational Research Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. Preoperative MRI consistent with a primary intracranial malignant brain tumor. 2. Must be 18 years of age or older. 3. Patient eligible for debulking surgery/resection.

Exclusion criteria

1. Inability to obtain pre-operative IV access. 2. Use of Tru Niagen, Basis (or any other nicotinamide riboside (NR)-containing NAD+ booster) or niacin supplements within one month prior to Study Visit 1. 3. Participation in studies involving investigational drug(s) within 30 days prior to Study Visit 1 4. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Study Visit 1 (participants may not donate blood any time during the study, through the final study day) 5. Presence of any condition that, in the opinion of Dr. Field, compromises participant safety or data integrity or the participant's ability to complete study days. 6. Pregnancy, lactation or \< 9 months postpartum from the Study Visit 1 date.

Design outcomes

Primary

MeasureTime frameDescription
Subtyping of GBM tumors as Classical, Proneural or MES (based on RNA-seq)2 monthsResected tumor tissue will undergo routine testing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026