Hyperpolarized Carbon-13 Pyruvate Imaging for Traumatic Brain Injury
(HPTBI Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-60 with a confirmed traumatic brain injury (TBI) based on specific criteria, including Glascow coma scale scores and CT scans. Participants must have had the injury within the last 30 days and be able to consent in English or Spanish. Excluded are those with non-TBI related brain abnormalities, metal in their head that affects MRI, severe mental health issues, drug influence at scanning time, or any MRI contraindications.

Inclusion Criteria

My traumatic brain injury happened less than 30 days ago.

Ability to understand and willingness to sign a written informed consent

You have a documented and confirmed traumatic brain injury with a Glasgow Coma Scale score of 10-15 or loss of consciousness for more than 10 minutes.

+3 more

Exclusion Criteria

Any contraindication per MRI Screening Form including implants contraindicated at 3T, pacemakers, Implantable Cardioverter Defibrillator (ICD), claustrophobia

Medically unstable including heart failure, severe left ventricular outflow tract (LVOT) obstruction, unstable angina, pregnancy, lactating

Subjects who are receiving any other investigational agents

+10 more

Participant Groups

The study tests how well hyperpolarized carbon-13 pyruvate compounds work as imaging agents to show changes in brain metabolism after TBI. It aims to assess mitochondrial dysfunction and cerebral glycolysis using advanced imaging techniques in patients who've recently suffered from TBI.

2Treatment groups

Experimental Treatment

Group I: Hyperpolarized [2-13C] PyruvateExperimental Treatment1 Intervention

Injection with hyperpolarized \[2-13C\] Pyruvate during MRI.

Group II: Hyperpolarized [1-13C] PyruvateExperimental Treatment1 Intervention

Injection with hyperpolarized \[1-13C\] Pyruvate during MRI.