Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT03849963

Conditions

Brain Metabolism

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Brain Metabolism

Study ID

NCT03849963

Start date

Jul 30, 2030

Status verified date

Mar, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

28 participants

Anticipated

Interventions and Outcome Measures

Arms

Hyperpolarized [13C]pyruvate

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

Primary outcome measure

  • Development of 13C ratio maps in the brain of healthy participants [ Time Frame: Measurements made during study scan ]

Central Contacts and Locations

Locations

UT Southwestern - Advanced Imaging Research Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Jeannie D Baxter, RN

214-645-2726jeannie.baxter@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-03-12.