MRI tracer could expose hidden brain energy crisis after head injury

NCT ID NCT03502967

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First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing whether a special MRI tracer called hyperpolarized pyruvate can detect changes in brain energy use after a traumatic brain injury (TBI). The study will compare images from people who had a TBI within the past 30 days with images from healthy volunteers. The goal is to see if this tracer can reveal altered metabolism in injured brains, which might help doctors better understand and monitor brain injuries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hyperpolarized pyruvate injection, a contrast agent used during MRI scans to visualize brain metabolism
What this could lead to
If successful, this imaging technique could help doctors see how the brain uses energy after injury, potentially guiding treatment decisions and monitoring recovery.
What could go wrong
This is an early-phase study with a small number of participants. The imaging technique may not reliably distinguish TBI patients from healthy controls, and the injected agent carries risks like any contrast material.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: TBI Patients * Injury occurred within 30 days * Documented and verified TBI by Glascow coma scal 10-15 and/or Loss of Consciousness \>10 minutes. * Head Computed Tomography at admission. ALL Subjects: * 18 through 60 years of age. * Ability to understand the the willingness to sign a writteninformed consent. * All races and ethnicities will be included; subjects must be able to read and speak either the English or Spanish language. Exclusion Criteria: * Non-traumatic structural brain abnormality identified on head CT. * Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions. * Penetrating TBI. * Significant anatomic distortion of the brain identified on CT images, such as large hematomas, herniation, intraventricular hemorrhage, extensive subarachnoid hemorrhage, hydrocephalus. * Significant polytrauma that would interfere with follow-up and outcome assessment. * Patients on psychiatric hold. * Major debilitating mental health disorders including, but not limited to schizophrenia and bipolar disorder that would limit compliance with study requirements. * 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. * Any contraindication per MRI Screening Form including * Implants contraindicated at 3T, pacemakers * Implantable Cardioverter Defibrillator (ICD) * Claustrophobia * Prisoners or patients in custody. * Medically unstable including * Heart failure * Severe left ventricular outflow tract (LVOT) obstruction * Unstable angina * Pregnancy * Lactating * Subjects who are receiving any other investigational agents.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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How to take part

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  1. The places running it

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Contacts and locations

Locations

  • UT Southwestern - Advanced Imaging Research Center

    Dallas, Texas, 75390, United States

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