Imaging oxidative metabolism and neurotransmitter synthesis in the brain
Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain
University of Texas Southwestern Medical Center · NCT03849963
This project tests whether two types of hyperpolarized 13C‑pyruvate MRI scans can reliably measure brain energy use and neurotransmitter-related metabolism in healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03849963 on ClinicalTrials.gov |
What this trial studies
This pilot observational study uses hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate as MRI probes to image oxidative metabolism and neurotransmitter synthesis in the human brain. Ten healthy adults will be imaged with [1-13C]pyruvate and ten with [2-13C]pyruvate, with each subject scanned twice within a 45-minute interval to test repeatability. An additional eight subjects will receive both substrates to allow direct comparison of the two probes. All imaging is performed at UT Southwestern's Advanced Imaging Research Center using 3T MRI-compatible protocols in participants without neurological disease or MRI contraindications.
Who should consider this trial
Good fit: Healthy adults aged 18–60 with no neurological abnormalities, no MRI contraindications, and the ability to read/speak English are the intended participants.
Not a fit: People with major neurologic disease, MRI‑incompatible implants, or those using illicit drugs or antiepileptic drugs at the time of scanning are unlikely to benefit and should not expect therapeutic effects from participation.
Why it matters
Potential benefit: If successful, this could provide a noninvasive way to visualize brain metabolism and neurotransmitter production, which may improve diagnosis and monitoring of neurologic conditions.
How similar studies have performed: Hyperpolarized 13C imaging has shown promising results in preclinical studies and in human cancer imaging, and limited human brain studies exist, but applying both [1-13C] and [2-13C] pyruvate for neurotransmitter synthesis imaging is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 through 60 years of age. * Healthy, with no neurological abnormalities. * Ability to understand and the willingness to sign a written informed consent. * All races and ethnicities will be included; subjects must be able to read and speak the English language. Exclusion Criteria: * Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions * Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements * Under influence of illicit drugs which are known to alter brain physiology/metabolism including, but not limited to cocaine, lysergic acid diethylamide (LSD), and marijuana at the time of MRI/MRSI scanning. * Under influence of antiepileptic drugs at the time of MRI/MRSI scanning. * Any contraindication per MRI Screening Form including * Implants contraindicated at 3T, pacemakers * Implantable Cardioverter Defibrillator (ICD) * Claustrophobia * Medically unstable including * Heart failure * Severe left ventricular outflow tract (LVOT) obstruction * Unstable angina * Pregnancy * Lactating
Where this trial is running
Dallas, Texas
- UT Southwestern - Advanced Imaging Research Center — Dallas, Texas, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metabolism