Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-11

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants in surgery

Surgical removal of the GBM tumor.

Surgical removal of the GBM tumor

Intervention Type PROCEDURE

Surgical removal of the GBM tumor

d4-NAM infusion

Intervention Type 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.

Interventions

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Surgical removal of the GBM tumor

Intervention Type PROCEDURE

d4-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.

Intervention Type OTHER

Other Intervention Names

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Nicotinamide

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No