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Assessing Brain Metabolism Using MRS With Deuterated Glucose

ConditionGlioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Healthy adults and adult patient referrals from the UCSF Neuro-Oncology Service and Department of Neurological Surgery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Deuterated Glucose

    Drug

    Given orally

  • Magnetic Resonance Imaging (MRI)

    Procedure/Surgery

    Imaging procedure performed at University of California, San Francisco

  • Blood Sample

    Procedure/Surgery

    Capillary blood from the fingertip

  • MR spectroscopy (MRS)

    Procedure/Surgery

    Imaging procedure performed at University of California, San Francisco

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Cohort 1: Healthy Controls4 interventions
Group B: Cohort 2: Glioma participants (Single Time point)4 interventions
Group C: Cohort 3: Glioma participants (Multiple Time points)4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day of imaging (1 day)
2

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.

Time frame
Day of imaging (1 day)
3

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.

Time frame
Day of imaging (1 day)
4

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.

Time frame
Up to 21 days after the completion of non-investigational treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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