Imaging of Traumatic Brain Injury Metabolism Using Hyperpolarized Carbon-13 Pyruvate

Enrolling by invitation · Early Phase 1

Conditions studied: Traumatic Brain Injury

In brief

This project is to evaluate sensitivity and specificity of hyperpolarized 13C-pyruvate as imaging agents of altered cerebral glycolysis and mitochondrial dysfunction and assess pyruvate utilization in mitochondria in Traumatic Brain Injury (TBI) patients.

Key facts

Study ID

NCT03502967

Run by

University of Texas Southwestern Medical Center

People needed

60

Starts

2018-06-01

Expected to finish

2026-06-30

Last updated by the study team

2025-08-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UT Southwestern - Advanced Imaging Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.