Assessing Brain Metabolism Using MRS With Deuterated Glucose

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Assessing Brain Metabolism Using MRS With Deuterated Glucose

Study Purpose

This study will investigate the use of Hydrogen 1 (1H) magnetic resonance spectroscopy (MRS) with deuterated glucose (2H-glucose) to detect dynamic glucose uptake in the brain.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
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. Participants must be >= 18 years old.

- Cohort 1: Healthy controls.

- Cohort 2: Participants with histological proven glioma who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion > 4 cc) based on a prior MR scan, Karnofsky performance status of >=70 and life expectancy > 4 weeks.

- Cohort 3: Participants with histologically proven glioma who will be undergoing any treatment, Karnofsky performance status of >=70 and life expectancy > 12 weeks.

2. Participants must not have any significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the subject's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent. 3. Participants must not have a history of any other cancer unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years. 4. Participants must not be pregnant or breast-feeding. Persons of childbearing potential are required to obtain a negative serum or urine pregnancy test within 14 days of the scan. Effective contraception (men and women) must be used in subjects of childbearing potentials. 5. Participants must sign an informed consent indicating that they are aware of the investigational nature of the study.

Exclusion Criteria:

Participants must be excluded from participating in this study if they are not able to comply with the study and/or follow-up procedures. 1. Participants exceeding the weight limitations of the scanner (300 pounds) 2. Inability to lie still for the entire imaging time (e.g., cough, severe arthritis, etc.) 3. Inability to complete the study due to other reasons (severe claustrophobia, MR incompatible medical implants or devices, inability to comply with pre-procedure fasting, etc.) 4. Pre-examination blood glucose level of > 120 mg/dL as measured by point of care finger stick blood glucose test prior to MR examination. 5. Participants, either healthy volunteers (recruited for cohort 1) or participants with glioma (for cohorts 2 &3), have history of diabetes mellitus.

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.	NCT06594315
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.	University of California, San Francisco
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yan Li, PhD
Principal Investigator Affiliation	University of California, San Francisco
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Additional Details

PRIMARY OBJECTIVE: 1. To define the most appropriate imaging parameters of 1H MRS for obtaining deuterium-labeled glucose metabolism (Cohorts 1 and 2). 2. To evaluate treatment induced metabolic changes after the administration of 2H-glucose in participants with glioma (Cohort 3). OUTLINE: Participants with and without glioma will be evaluated to develop a robust strategy for obtaining 2H-glucose metabolism in twenty healthy participants (cohort 1) and thirty participants with glioma (cohort 2), while the remaining thirty glioma participants will be studied at baseline and after completion of non-investigational therapy (cohort 3).

Arms & Interventions

Arms

: Cohort 1: Healthy Controls

Twenty healthy controls for will have 2H-glucose metabolism in measured for development of robust strategy in optimizing acquisition parameters.

: Cohort 2: Glioma participants (Single Time point)

Thirty participants with glioma who may or may not have received prior treatment for testing the optimized imaging protocol developed in Cohort 1.

: Cohort 3: Glioma participants (Multiple Time points)

Thirty participants who will receive non-investigational treatment for glioma enrolled to test the evaluation for treatment induced metabolic changes at baseline and post- non-investigational treatment.

Interventions

Drug: - Deuterated Glucose

Given orally

Procedure: - Magnetic Resonance Imaging (MRI)

Imaging procedure performed at University of California, San Francisco

Procedure: - Blood Sample

Capillary blood from the fingertip

Procedure: - MR spectroscopy (MRS)

Imaging procedure performed at University of California, San Francisco

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.

University of California, San Francisco, San Francisco 5391959, California 5332921

Status

Address

University of California, San Francisco

San Francisco 5391959, California 5332921, 94143