Clinical trial NCT06594315: Assessing Brain Metabolism Using MRS With Deuterated Glucose
Official title: Assessing Brain Metabolism Using 1H MRS With Deuterated Glucose
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Glioma
Keywords: Glucose Metabolism
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults and adult patient referrals from the UCSF Neuro-Oncology Service and Department of Neurological Surgery.

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).

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.

Primary outcomes:
measure: Signal-to-noise ratio (Cohort 1 & 2)
timeFrame: Day of imaging (1 day)
measure: Mean difference in metabolite concentrations (Cohort 1 & 2)
timeFrame: Day of imaging (1 day)
measure: Mean difference in fractional enrichment (Cohort 1 & 2)
timeFrame: Day of imaging (1 day)
measure: Mean metabolic turnover over time (Cohort 3)
timeFrame: Up to 21 days after the completion of non-investigational treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yan Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: