Assessing Brain Metabolism Using MRS With Deuterated Glucose

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Glioma

Treatments: Procedure: MR spectroscopy (MRS); Procedure: Blood Sample; Drug: Deuterated Glucose; Procedure: Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Other

Identifiers

NCT06594315

NCI-2022-08563 (Registry Identifier)

22922

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

80 participants in 3 patient groups

Cohort 1: Healthy Controls

Description:

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

Treatment:

Procedure: Magnetic Resonance Imaging (MRI)

Drug: Deuterated Glucose

Procedure: Blood Sample

Procedure: MR spectroscopy (MRS)

Cohort 2: Glioma participants (Single Time point)

Description:

Thirty participants with glioma who may or may not have received prior treatment for testing the optimized imaging protocol developed in Cohort 1.

Treatment:

Procedure: Magnetic Resonance Imaging (MRI)

Drug: Deuterated Glucose

Procedure: Blood Sample

Procedure: MR spectroscopy (MRS)

Cohort 3: Glioma participants (Multiple Time points)

Description:

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.

Treatment:

Procedure: Magnetic Resonance Imaging (MRI)

Drug: Deuterated Glucose

Procedure: Blood Sample

Procedure: MR spectroscopy (MRS)