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

• Status: Enrolling by invitation
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

Criteria

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.