Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

Active, not recruiting

• Conditions: Glioblastoma Multiforme
• Interventions: Procedure: Surgical removal of the GBM tumor; Other: d4-NAM infusion

• Registration Number: NCT06054529
• Lead Sponsor: AdventHealth Translational Research Institute

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-11
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-26
• Primary Completion: 2024-01-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants in surgery	Surgical removal of the GBM tumor	Surgical removal of the GBM tumor.
Participants in surgery	d4-NAM infusion	Surgical removal of the GBM tumor.

Primary Outcome Measures

Name	Time	Method
Subtyping of GBM tumors as Classical, Proneural or MES (based on RNA-seq)	2 months	Resected tumor tissue will undergo routine testing

Trial Locations

Locations (1)

AdventHealth Translational Research Institute; 🇺🇸 Orlando, Florida, United States