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NCT Number: NCT03849963

Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

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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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern - Advanced Imaging Research Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Jeannie D Baxter, RN

CONTACT

[email protected]

214-645-2726

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of 13C ratio maps in the brain of healthy participants

    Time frame: Measurements made during study scan

    Product ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C imaging

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: HP Brain

Important dates

Study start
2030
Primary completion
2030
Study completion
2030
First posted
Feb 21, 2019
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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