GliomaNCT06594315
Assessing Brain Metabolism Using MRS With Deuterated Glucose
An observational study of Glioma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioma
- What is being tested?
- Deuterated Glucose, Magnetic Resonance Imaging (MRI) and Blood Sample
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults and adult patient referrals from the UCSF Neuro-Oncology Service and Department of Neurological Surgery.
Who may be able to join
- 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.
- Cohort 3: Participants with histologically proven glioma who will be undergoing any treatment.
- 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 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Wendy Ma, 415-514-4418, Wendy.Ma@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Assessing Brain Metabolism Using 1H MRS With Deuterated Glucose
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To define the most appropriate imaging parameters of 1H MRS for obtaining deuterium-labeled glucose metabolism (Cohorts 1 and 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
- Being tested
- Deuterated Glucose, Magnetic Resonance Imaging (MRI), Blood Sample, MR spectroscopy (MRS)
- Keywords
- Glucose Metabolism
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterated GlucoseDrug
Also called Hydrogen gas (H2) glucose, [6,6'-2H2] glucose
Given orally
Magnetic Resonance Imaging (MRI)Procedure or surgery
Also called MRI
Imaging procedure performed at University of California, San Francisco
Blood SampleProcedure or surgery
Capillary blood from the fingertip
MR spectroscopy (MRS)Procedure or surgery
Also called MRS
Imaging procedure performed at University of California, San Francisco
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Healthy Controls | Twenty healthy controls for will have 2H-glucose metabolism in measured for development of robust strategy in optimizing acquisition parameters. Receives: 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. Receives: 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. Receives: Drug: Deuterated Glucose; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Blood Sample; Procedure: MR spectroscopy (MRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 21 days after the completion of non-investigational treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Jul 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Li, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594315
- Sponsor's protocol ID
- 22922
- Other IDs
- NCI-2022-08563
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Brain Metabolism Using 1H MRS With Deuterated Glucose
- ClinicalTrials.gov ID
- NCT06594315
- Acronym / sponsor ID
- 22922
- Conditions
- Glioma
- Keywords
- Glucose Metabolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To define the most appropriate imaging parameters of 1H MRS for obtaining deuterium-labeled glucose metabolism (Cohorts 1 and 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Healthy Controls | – | Drug: Deuterated Glucose, Procedure: Magnetic Resonance Imaging (MRI), Procedure: Blood Sample, Procedure: MR spectroscopy (MRS)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) | – | Drug: Deuterated Glucose, Procedure: Magnetic Resonance Imaging (MRI), Procedure: Blood Sample, Procedure: MR spectroscopy (MRS)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) | – | Drug: Deuterated Glucose, Procedure: Magnetic Resonance Imaging (MRI), Procedure: Blood Sample, Procedure: MR spectroscopy (MRS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults and adult patient referrals from the UCSF Neuro-Oncology Service and Department of Neurological Surgery.
Key inclusion criteria (7 listed)
- Participants must be >= 18 years old
- 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 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deuterated GlucoseAlso: Hydrogen gas (H2) glucose, [6,6'-2H2] glucoseGiven orally | Drug | Cohort 1: Healthy Controls, Cohort 2: Glioma participants (Single Time point), Cohort 3: Glioma participants (Multiple Time points) |
| Magnetic Resonance Imaging (MRI)Also: MRIImaging procedure performed at University of California, San Francisco | Procedure or surgery | Cohort 1: Healthy Controls, Cohort 2: Glioma participants (Single Time point), Cohort 3: Glioma participants (Multiple Time points) |
| Blood SampleCapillary blood from the fingertip | Procedure or surgery | Cohort 1: Healthy Controls, Cohort 2: Glioma participants (Single Time point), Cohort 3: Glioma participants (Multiple Time points) |
| MR spectroscopy (MRS)Also: MRSImaging procedure performed at University of California, San Francisco | Procedure or surgery | Cohort 1: Healthy Controls, Cohort 2: Glioma participants (Single Time point), Cohort 3: Glioma participants (Multiple Time points) |
Primary outcome
Signal-to-noise ratio (Cohort 1 & 2)
Time frame: Day of imaging (1 day)
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
Mean difference in metabolite concentrations (Cohort 1 & 2)
Time frame: Day of imaging (1 day)
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.
Mean difference in fractional enrichment (Cohort 1 & 2)
Time frame: Day of imaging (1 day)
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.
Mean metabolic turnover over time (Cohort 3)
Time frame: Up to 21 days after the completion of non-investigational treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Li, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Ma ((415) 514-4418, Wendy.Ma@ucsfe.du), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-noise ratio (Cohort 1 & 2) (time frame: Day of imaging (1 day)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.