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NCT Number: NCT06054529

Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to obtain pre-operative IV access.
  • 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.
  • Participation in studies involving investigational drug(s) within 30 days prior to Study Visit 1
  • 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)
  • 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.
  • Pregnancy, lactation or < 9 months postpartum from the Study Visit 1 date.

Treatment and study plan

Surgical removal of the GBM tumor

Procedure

Surgical removal of the GBM tumor

d4-NAM infusion

Other

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.

Other names: Nicotinamide

Primary outcomes

  1. Subtyping of GBM tumors as Classical, Proneural or MES (based on RNA-seq)

    Time frame: 2 months

    Resected tumor tissue will undergo routine testing

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Registry information

Acronym: GBM-FLUX2

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 26, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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