Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-30

Study Completion Date

2026-12-31

Brief Summary

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Investigators propose to develop hyperpolarized \[13C\]-labeled pyruvate as potential imaging probes to assess two essential in vivo processes in cerebral metabolism: oxidative metabolism and synthesis of a neurotransmitter in this observational study.

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Detailed Description

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Investigators will perform a pilot study to test the translational feasibility by evaluating sensitivity and repeatability of hyperpolarized \[1-13C\]pyruvate and \[2-13C\]pyruvate in healthy human subjects (n =10 each). Each subject will be imaged twice using the same hyperpolarized substrate with an interval (\<45min) between the injections to evaluate repeatability. Finally, eight subjects will be imaged with both hyperpolarized \[1-13C\]pyruvate and \[2-13C\]pyruvate for comparison.

Conditions

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Brain Metabolism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hyperpolarized [13C]pyruvate

Hyperpolarized stable isotope injection (\[13C\]pyruvate) during magnetic resonance spectroscopic imaging

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes