Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brain Metabolism. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Development of 13C ratio maps in the brain of healthy participants [Time frame: Measurements made during study scan]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- UT Southwestern - Advanced Imaging Research Center — Dallas
Identifiers
NCT: NCT03849963 · STU-2018-0013