Assessing Brain Metabolism Using MRS With Deuterated Glucose

Active, not recruiting

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

• Registration Number: NCT06594315
• Lead Sponsor: University of California, San Francisco

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).

Study Timeline

• Study Start: 2022-07-20
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2: Glioma participants (Single Time point)	Deuterated Glucose	Thirty participants with glioma who may or may not have received prior treatment for testing the optimized imaging protocol developed in Cohort 1.
Cohort 1: Healthy Controls	Deuterated Glucose	Twenty healthy controls for will have 2H-glucose metabolism in measured for development of robust strategy in optimizing acquisition parameters.
Cohort 1: Healthy Controls	Magnetic Resonance Imaging (MRI)	Twenty healthy controls for will have 2H-glucose metabolism in measured for development of robust strategy in optimizing acquisition parameters.
Cohort 1: Healthy Controls	Blood Sample	Twenty healthy controls for will have 2H-glucose metabolism in measured for development of robust strategy in optimizing acquisition parameters.
Cohort 1: Healthy Controls	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)	Magnetic Resonance Imaging (MRI)	Thirty participants with glioma who may or may not have received prior treatment for testing the optimized imaging protocol developed in Cohort 1.
Cohort 2: Glioma participants (Single Time point)	Blood Sample	Thirty participants with glioma who may or may not have received prior treatment for testing the optimized imaging protocol developed in Cohort 1.
Cohort 2: Glioma participants (Single Time point)	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)	Deuterated Glucose	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.
Cohort 3: Glioma participants (Multiple Time points)	Magnetic Resonance Imaging (MRI)	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.
Cohort 3: Glioma participants (Multiple Time points)	Blood Sample	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.
Cohort 3: Glioma participants (Multiple Time points)	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.

Primary Outcome Measures

Name	Time	Method
Signal-to-noise ratio (Cohort 1 & 2)	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)	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)	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)	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States