Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06054529
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AdventHealth Translational Research Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stephen Gardell, PhD
Principal Investigator Affiliation	AdventHealth Translational Research Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Arms & Interventions

Arms

: Participants in surgery

Surgical removal of the GBM tumor.

Interventions

Procedure: - Surgical removal of the GBM tumor

Surgical removal of the GBM tumor

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orlando, Florida

Status

Recruiting

Address

AdventHealth Translational Research Institute

Orlando, Florida, 32804

Site Contact

Recruitment Dept

stephen.gardell@adventhealth.com

407-303-7100

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