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

NCT03502967 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: STU 072017-009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; TBI

Outcome Measures

Primary Outcomes (1)

• [1-13C]lactate-to-H13CO3- ratio from [1-13C]pyruvate or [2-13C]lactate-to-[5-13C]glutamate ratio from [2-13C]pyruvate

  Product ratio maps of lactate from pyruvate in the brain of TBI patients as compared to those of healthy controls.

  One visit of three hours: 2 bolus injections during MRI with 45 minute rest period between the two

Study Arms (2)

Hyperpolarized [1-13C] Pyruvate

EXPERIMENTAL

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

Drug: Hyperpolarized [1-13C] Pyruvate

Hyperpolarized [2-13C] Pyruvate

EXPERIMENTAL

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

Drug: Hyperpolarized [2-13C] Pyruvate

Interventions

Hyperpolarized [1-13C] Pyruvate DRUG

Bolus injection of study drug

Also known as: HP Pyruvate Injection

Hyperpolarized [1-13C] Pyruvate

Hyperpolarized [2-13C] Pyruvate DRUG

Bolus injection of study drug

Also known as: HP Pyruvate Injection

Hyperpolarized [2-13C] Pyruvate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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:
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern - Advanced Imaging Research Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Pyruvic Acid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pyruvates; Keto Acids; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: TBI patients and healthy control subjects

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: June 1, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)