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MRI tracer could expose hidden brain energy crisis after head injury
NCT ID NCT03502967
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT Southwestern - Advanced Imaging Research Center
Dallas, Texas, 75390, United States
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