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Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03849963
Acronym
HP Brain
Enrollment
28
Registered
2019-02-21
Start date
2030-07-30
Completion date
2030-12-31
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metabolism

Brief summary

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.

Interventions

None listed

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Development of 13C ratio maps in the brain of healthy participantsMeasurements made during study scanProduct ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C imaging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026