NCT03502967
Imaging of Traumatic Brain Injury Metabolism Using Hyperpolarized Carbon-13 Pyruvate
Enrolling by Invitation
EARLY_PHASE1Ages 18–60InterventionalBasic scienceUniversity of Texas Southwestern Medical CenterInvestigator-initiated
~60 participants
Updated 2025-08-26 on ClinicalTrials.gov
What's tested:Hyperpolarized [1-13C] PyruvateHyperpolarized [2-13C] Pyruvate
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
[1-13C]lactate-to-H13CO3- ratio from [1-13C]pyruvate or [2-13C]lactate-to-[5-13C]glutamate ratio from [2-13C]pyruvate
Measured over One visit of three hours: 2 bolus injections during MRI with 45 minute rest period between the two
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
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
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.
What this trial measures
- [1-13C]lactate-to-H13CO3- ratio from [1-13C]pyruvate or [2-13C]lactate-to-[5-13C]glutamate ratio from [2-13C]pyruvateOne visit of three hours: 2 bolus injections during MRI with 45 minute rest period between the two
Product ratio maps of lactate from pyruvate in the brain of TBI patients as compared to those of healthy controls.