Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

• Conditions: Brain Metabolism

• Registration Number: NCT03849963
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2020-07-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 28

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of 13C ratio maps in the brain of healthy participants	Measurements made during study scan	Product ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C imaging

Trial Locations

Locations (1)

UT Southwestern - Advanced Imaging Research Center; 🇺🇸 Dallas, Texas, United States