Assessing Brain Metabolism Using MRS With Deuterated Glucose

NCT06594315 | Active Not Recruiting DMC FDA Drug

• 2 other identifiers: 22922NCI-2022-08563
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma

Keywords

Glucose Metabolism

Outcome Measures

Primary Outcomes (4)

• Signal-to-noise ratio (Cohort 1 & 2)

  The signal-to-noise ratio (SNR) in metabolite concentrations will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the regions of interest (ROIs) of the anatomic and metabolic lesions on the imaging scan. Peaks with SNR \> 5.0 are considered detectable

  Day of imaging (1 day)

• Mean difference in metabolite concentrations (Cohort 1 & 2)

  Mean difference in metabolite concentrations of 2H labeling of these metabolites will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the ROIs of the anatomic and metabolic lesions.

  Day of imaging (1 day)

• Mean difference in fractional enrichment (Cohort 1 & 2)

  Mean difference in fractional enrichment of 2H labeling of these metabolites will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the ROIs of the anatomic and metabolic lesions.

  Day of imaging (1 day)

• Mean metabolic turnover over time (Cohort 3)

  Estimates of the extent of change over time following non-investigational treatment obtained at the baseline and one repeated after receiving treatment will be compared.

  Up to 21 days after the completion of non-investigational treatment

Study Arms (3)

Cohort 1: Healthy Controls

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

Drug: Deuterated Glucose; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Blood Sample; Procedure: MR spectroscopy (MRS)

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.

Drug: Deuterated Glucose; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Blood Sample; Procedure: MR spectroscopy (MRS)

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.

Drug: Deuterated Glucose; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Blood Sample; Procedure: MR spectroscopy (MRS)

Interventions

Deuterated Glucose DRUG

Given orally

Also known as: Hydrogen gas (H2) glucose, [6,6'-2H2] glucose

Cohort 1: Healthy Controls; Cohort 2: Glioma participants (Single Time point); Cohort 3: Glioma participants (Multiple Time points)

Magnetic Resonance Imaging (MRI) PROCEDURE

Imaging procedure performed at University of California, San Francisco

Also known as: MRI

Cohort 1: Healthy Controls; Cohort 2: Glioma participants (Single Time point); Cohort 3: Glioma participants (Multiple Time points)

Blood Sample PROCEDURE

Capillary blood from the fingertip

Cohort 1: Healthy Controls; Cohort 2: Glioma participants (Single Time point); Cohort 3: Glioma participants (Multiple Time points)

MR spectroscopy (MRS) PROCEDURE

Imaging procedure performed at University of California, San Francisco

Also known as: MRS

Cohort 1: Healthy Controls; Cohort 2: Glioma participants (Single Time point); Cohort 3: Glioma participants (Multiple Time points)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults and adult patient referrals from the UCSF Neuro-Oncology Service and Department of Neurological Surgery.

You may qualify if:

• 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.
• 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.
• 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.
• 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.
• Participants must sign an informed consent indicating that they are aware of the investigational nature of the study

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Glucose; Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Yan Li, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: July 20, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)