Assessing Brain Metabolism Using MRS With Deuterated Glucose

NCT ID: NCT06594315

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2027-07-31

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.

Detailed Description

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).

Conditions

Glioma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1: Healthy Controls

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

Deuterated Glucose

Intervention Type: DRUG

Given orally

Magnetic Resonance Imaging (MRI)

Intervention Type: PROCEDURE

Imaging procedure performed at University of California, San Francisco

Blood Sample

Intervention Type: PROCEDURE

Capillary blood from the fingertip

MR spectroscopy (MRS)

Intervention Type: PROCEDURE

Imaging procedure performed at University of California, San Francisco

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.

Deuterated Glucose

Intervention Type: DRUG

Given orally

Magnetic Resonance Imaging (MRI)

Intervention Type: PROCEDURE

Imaging procedure performed at University of California, San Francisco

Blood Sample

Intervention Type: PROCEDURE

Capillary blood from the fingertip

MR spectroscopy (MRS)

Intervention Type: PROCEDURE

Imaging procedure performed at University of California, San Francisco

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.

Deuterated Glucose

Intervention Type: DRUG

Given orally

Magnetic Resonance Imaging (MRI)

Intervention Type: PROCEDURE

Imaging procedure performed at University of California, San Francisco

Blood Sample

Intervention Type: PROCEDURE

Capillary blood from the fingertip

MR spectroscopy (MRS)

Intervention Type: PROCEDURE

Imaging procedure performed at University of California, San Francisco

Interventions

Deuterated Glucose

Given orally

Intervention Type: DRUG

Magnetic Resonance Imaging (MRI)

Imaging procedure performed at University of California, San Francisco

Intervention Type: PROCEDURE

Blood Sample

Capillary blood from the fingertip

Intervention Type: PROCEDURE

MR spectroscopy (MRS)

Imaging procedure performed at University of California, San Francisco

Intervention Type: PROCEDURE

Other Intervention Names

Hydrogen gas (H2) glucose; [6,6'-2H2] glucose; MRI; MRS

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Li, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

NCI-2022-08563

Identifier Type: REGISTRY

Identifier Source: secondary_id

22922

Identifier Type: -

Identifier Source: org_study_id