Status:
ACTIVE_NOT_RECRUITING
Assessing Brain Metabolism Using MRS With Deuterated Glucose
Lead Sponsor:
University of California, San Francisco
Conditions:
Glioma
Eligibility:
All Genders
18+ years
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 chan...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06594315
Start Date
July 20 2022
End Date
July 31 2027
Last Update
September 18 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143