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Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients (GBM-FLUX2)

A

AdventHealth Translational Research Institute

Status

Active, not recruiting

Conditions

Glioblastoma Multiforme

Treatments

Other: d4-NAM infusion
Procedure: Surgical removal of the GBM tumor

Study type

Observational

Funder types

Other

Identifiers

NCT06054529
2063291

Details and patient eligibility

About

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

Enrollment

2 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

2 participants in 1 patient group

Participants in surgery
Description:
Surgical removal of the GBM tumor.
Treatment:
Procedure: Surgical removal of the GBM tumor
Other: d4-NAM infusion

Trial contacts and locations

1

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Central trial contact

Stephen Gardell, PhD

Data sourced from clinicaltrials.gov

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